Pharmaceutical Jobs

WE ARE EXPANDING OUR TEAM

EirGen Pharma is expanding and adding a second site locally in Waterford, as part of this growth we have a number of key positions which all come with a competitive salary and benefits package as well as opportunity to join an exciting global pharmaceutical company.

 

To apply for any of the roles listed, or to obtain further information, email us at hr@eirgen.com.

When applying for any of these positions, please include your CV, a Covering Letter and clearly state for which Job Position you are applying.

EirGen Job Opportunities

Please click below for a recent advertisement which we recorded showcasing the opportunities that are currently open to interested candidates:

In the event that the below links do not grant you access to apply, please forward your application to HR@EirGen.com mentioning the relevant position in your title.

REGULATORY AFFAIRS OFFICER

Reporting to: Senior Regulatory Affairs Officer and based at our R&D Centre on the Cork Road

 What will you be doing?

  • Working within a team, responsible for a number of key projects with the following as examples
    • Dossier preparation in collaboration with our in-house R&D team (our R&D capacity is substantial with over 60 in the team and expanding all of the time) to support our generics portfolio. Dosage forms include high containment, tablets, capsules, soft gel capsules, dry powder inhalers and injectables. Territories are diverse and include US, EU, Japan and many ROW territories.
    • Licensing support for OPKO’s portfolio new drug developments – some are authorised (one with an NDA in the US) and others are at various stages of clinical development with EirGen as the CMC Centre of Excellence and Supply Chain. Working with our licensing partners in US, EU and Japan for these new projects. IND support, Paediatric development and involvement in PIPs and PMRs for EU and US.
    • Biologics – our new R&D facility houses a sterile fill finish line for manufacture of one of OPKO’s new biological products. Our Regulatory team will be closely involved in dossier preparation for global registration on completion of the Clinical program.
    • Veterinary portfolio regulatory strategy – EirGen is developing a portfolio of new drugs for use in small animals with primary focus on US, followed by EU. Interaction with FDA and EMA on filing strategy and dossier content.

 

What we need from YOU:

  • You MUST be passionate about Regulatory Affairs
  • A degree in Chemistry or Pharmacy (or a related discipline)
  • Ideally you will have 1 -2 year Regulatory experience, however other CMC focused Pharma experience considered
  • Self-starter who enjoys working in a fast paced environment
  • You MUST enjoy working as part of a team and be fun and friendly

 

What makes us different:

  • We are a fun and exciting place to work!
  • We have an incredibly broad range of products; Generics and New Drug developments; Human and Veterinary; we have a strong Clinical team in-house; substantial R&D capacity – all of which makes us very autonomous and self-resourced to deliver projects
  • We encourage growth from within and like to promote our employees where we can
  • We want to develop our employees and so we encourage them to undertake further training and courses wherever possible
  • Diversity matters to us
  • Our open door policy ensures that everyone’s ideas are heard
  • Not too many pharma companies can boast that they have a purpose built R&D Centre located in the sunny South-East of Ireland!
  • Everyone sits together in the canteen – it doesn’t matter who you are!

 

Want to know more about EirGen?

  • EirGen Pharma was founded in 2005 by two budding entrepreneurs, Patsy and Tom who had buckets of pharma experience and a passion to grow their MBA programme idea
  • The successful growth of EirGen attracted one of the world’s best known pharmaceutical investors Dr Philip Frost and his company OPKO Health Inc. to purchase EirGen Pharma in May 2015 and go on to significantly invest in the Waterford sites
  • EirGen Pharma has two sites based on the outskirts of Waterford city, one is our Commercial Centre where the manufacture of our solid oral dosage forms occurs and the other is a purpose built, state of the art, R&D Centre which includes a sterile fill finish suite
  • We are listed on the New York Stock Exchange
  • We currently employ over 200 people and will continue to grow
  • We are now the International Research and Development and Supply Chain Centre of Excellence for OPKO Health Inc..

 

At EirGen Pharma we are taking careers to new heights, and as a result have achieved some big milestones along the way:

  • Winners of the Pharma Company of the Year (SME) in 2017
  • In 2015 our high containment soft gel filling line became fully operational
  • In June 2017 our office space at our R&D Centre opened and our Regulatory Team moved in!
  • Our new R&D and Microbiology labs are due to open in April 2018 with full production planned for 2019 – so exciting times ahead!

In short, we are a rapidly growing pharmaceutical company and we need more great people to join our team to keep growing! We pride ourselves in recruiting, developing, and retaining the best people.

Want to be a part of all of this? Then send your CV to HR@EirGen.com to apply for our Regulatory Affairs Officer role today and become a fellow EirGener!!

CLICK TO APPLY

SENIOR REGULATORY AFFAIRS OFFICER

Reporting to: Regulatory Affairs Manager and based at our R&D Centre on the Cork Road

 What will you be doing?

  • Supervision, coaching and training of a number of Regulatory Affairs Officers in the Regulatory Team
  • Responsible for a number of key projects with the following as examples
    • Dossier preparation in collaboration with our in-house R&D team (our R&D capacity is substantial with over 60 in the team and expanding all of the time) to support our generics portfolio. Dosage forms include high containment, tablets, capsules, soft gel capsules, dry powder inhalers and injectables. Territories are diverse and include US, EU, Japan and many ROW territories.
    • Licensing support for OPKO’s portfolio new drug developments – some are authorised (one with an NDA in the US) and others are at various stages of clinical development with EirGen as the CMC centre of excellence and supply chain. Working with our licensing partners in US, EU and Japan for these new projects. IND support, Paediatric development and involvement in PIPs and PMRs for EU and US.
    • Biologics – our new R&D facility houses a sterile fill finish line for manufacture of one of OPKO’s new biological products. Our Regulatory team will be closely involved in dossier preparation for global registration on completion of the Clinical program.
    • Veterinary portfolio regulatory strategy – EirGen is developing a portfolio of new drugs for use in small animals with primary focus on US, followed by EU. Interaction with FDA and EMA on filing strategy and dossier content.

 

What we need from YOU:

  • You MUST be passionate about Regulatory Affairs
  • A degree in Chemistry or Pharmacy (or a related discipline)
  • You MUST have at least 3+ years’ Regulatory experience but ideally 5 – 8 years desired
  • Enjoy the coordination of tasks and management of workloads
  • Self-starter who enjoys working in a fast paced environment
  • You MUST enjoy working as part of a team and be fun and friendly

 

What makes us different:

  • We are a fun and exciting place to work!
  • We have an incredibly broad range of products; Generics and New Drug developments; Human and Veterinary; we have a strong Clinical team in-house; substantial R&D capacity – all of which makes us very autonomous and self-resourced to deliver projects.
  • We encourage growth from within and like to promote our employees where we can
  • We want to develop our employees and so we encourage them to undertake further training and courses wherever possible
  • Diversity matters to us
  • Our open door policy ensures that everyone’s ideas are heard
  • Not too many pharma companies can boast that they have a purpose built R&D Centre located in the sunny South-East of Ireland!

 

What will you get if you work with us?

Aside from having a great day at work, you’ll also get:

  • A great work environment with lots of fun
  • A chance to work with like-minded people
  • Be part of a team of people who work together to make life-saving products
  • Work in Ireland’s Pharma Company (SME) of the Year
  • A great financial package to meet your knowledge and experience
  • A company contributed pension
  • Health Insurance
  • Extra day’s holidays
  • Company sponsored events and nights out
  • And lots of other stuff!!

 

 At EirGen Pharma we are taking careers to new heights, and as a result have achieved some big milestones along the way:

  • Winners of the Pharma Company of the Year (SME) in 2017
  • In 2015 our high containment soft gel filling line became fully operational
  • In June 2017 our office space at our R&D facility opened and our Regulatory Team moved in!
  • Our new R&D and Microbiology labs are due to open in April 2018 with full production planned for 2019 – so exciting times ahead!

 

In short, we are a rapidly growing pharmaceutical company and we need more great people to join our team to keep growing! We pride ourselves in recruiting, developing, and retaining the best people.

Want to be a part of all of this? Then send your CV to HR@EirGen.com to apply for our Senior Regulatory Affairs Officer role today and become a fellow EirGener!!

CLICK TO APPLY

QUALITY ASSURANCE CONTROLLER

We have a vacancy for a QA Controller. The purpose of this role is to support the QA team with the development, implementation and maintenance of EirGen quality standards and systems to ensure that products comply with Marketing Authorisations, documentation, specifications and cGMPs.  The ideal candidate will have a third level qualification incorporating Quality and a minimum of 2 years relevant experience in a related role.

CLICK TO APPLY

DEVELOPMENT TECHNOLOGIST – R&D FORMULATION DEVELOPMENT

Our R&D Formulations Team have a NEW vacancy for a Development Technologist to join their growing Team. This role is responsible for the Formulation Development of Generic and New Drug Products through applying a thorough knowledge of all processes involved in the manufacture of pharmaceutical products. The ideal candidate will hold a third level qualification in pharmaceutical science or related discipline and will have three years’ experience working in the pharmaceutical industry, preferably in an operational setting. Practical experience of formulation development would be highly advantageous.

CLICK TO APPLY

FORMULATION DEVELOPMENT TEAM LEADER

Our R&D Formulations Team have a NEW vacancy for a Formulation Development Team Leader to join their growing Team. This role is responsible for the coordination of formulation development activities at EirGen Pharma. The ideal candidate will be qualified to a minimum of degree level in a pharmaceutical science or related discipline and will have at least five years’ experience working in a formulation development, process development, manufacturing, or related technical environment, including previous supervisory experience. Analytical/laboratory experience would be advantageous.

CLICK TO APPLY

FORMULATION SCIENTIST

Our R&D Formulations Team have a new vacancy for a Formulation Scientist. This role is responsible for the formulation development of both Generic and New Drug Product development. The ideal candidate will be qualified to a minimum of degree level in a pharmaceutical science or related discipline and will have at least five years’ experience working in a formulation development, process development, manufacturing, or related technical environment. Fill Finish and Dry Powder Inhalations (DPI) experience is advantageous.

CLICK TO APPLY

FORMULATION CONTROLLER

Our R&D Formulations Team have a vacancy for a Formulation Controller. The purpose of this role is to provide administrative support to the R&D Formulation function in order to ensure all business milestones are met. The ideal candidate will have a third level qualification or equivalent work experience including previous administration training. Experience working in a related technical environment and SAP experience would be an advantage.

CLICK TO APPLY

QUALITY ASSURANCE OFFICER – R&D

Our growing Quality Team have a NEW VACANCY for a Quality Assurance Officer – R&D. The purpose of this role is to support the R&D Quality Assurance Team Lead, Quality Manager and Head of Quality with the development, implementation and maintenance of the quality standards and systems to ensure that products comply with procedures, specifications and cGMPs. The ideal candidate will have a Science Degree incorporating Quality Management and will have at least 3 years’ experience working in a GMP compliant role. Sterile manufacturing experience would be highly advantageous.

CLICK TO APPLY

SENIOR MICROBIOLOGIST

What will you be doing?

  • Supporting production in our shiny new state of the art Sterile Fill Finish production suite
  • Coaching and training junior members of the Microbiology Team
  • Using lots of new high-tech equipment including our MaldiTof and Qube Isolator
  • Keeping abreast of new Microbiology trends and technologies
  • Getting hands on with all the Microbiology bugs!

What we need from YOU:

  • You MUST be passionate about Microbiology (bug lovers wanted!)
  • A degree in Microbiology (or a related discipline)
  • You MUST have at least 5+ years’ Microbiology experience
  • Appreciate the importance of following SOPs and good GDP
  • Enjoy the coordination of tasks and management of workloads
  • Self-starter who enjoys working in a fast paced environment
  • You MUST enjoy working as part of a team and be fun and friendly

Earn extra credit by meeting the following criteria:

  • Previous Sterile Fill Finish experience is a HUGE bonus
  • People management skills will also earn you additional points

CLICK TO APPLY

MICROBIOLOGIST (LEVEL 3)

EirGen Pharma are seeking a Microbiologist to join their growing Microbiology Team based in their R&D Centre. This role will assist with the introduction of methods, practices and procedures to both QC and production and help to ensure aseptic and sterility assurances principle are implemented and maintained from project phase to routine operation. This role will also provide support and back up to the Senior Microbiologist and take on delegated tasks/projects as required. The ideal candidate for this role will be qualified to a minimum of Degree level in Microbiology or Biological Sciences and will have at least 4 years’ microbiology experience, ideally within a pharmaceutical environment. Previous sterile manufacturing experience would be highly advantageous.

CLICK TO APPLY

R&D DATA REVIEWER

EirGen Pharma’s R&D Analytical Team are seeking a Data Reviewer to support Product Development and Clinical Supply. This role will review all data associated with developing, transferring or validating analytical test methods as applicable. Ideal candidates will be qualified to a minimum of degree level in chemistry, pharmaceutical science or a related discipline with at least five years’ experience working in a related technical environment.

CLICK TO APPLY

R&D ANALYTICAL DEVELOPMENT CHEMIST

 

What will you be doing?

  • Working in EirGen’s new state of the art, purpose built R&D facility!
  • Developing, transferring and validating robust, sound analytical methods
  • Using your problem solving skills to troubleshoot methods
  • Analysing all raw materials, in process samples and finished products in a timely and efficient manner to ensure quality and efficacy of the product
  • Taking part in laboratory investigations
  • Attending internal project review meetings as required
  • Assisting in the preparation for customer/ regulatory inspections
  • Preparing submission documentation in support of license applications

What we need from YOU:

  • You MUST be passionate about R&D
  • A degree in Chemistry (or a related science discipline)
  • You MUST have at least 3+ years’ pharma lab based experience
  • Appreciate the importance of following SOPs and good GDP/GLP
  • Enjoy technical report writing
  • Self-starter who enjoys working in a fast paced environment
  • You MUST enjoy working as part of a team and be fun and friendly

 

Earn extra credit by meeting the following criteria:

  • Have experience in method development/transfer/validation
  • Be proficient in HPLC and Empower 3 Software

What’s our culture like?

  • We have an active Sports and Social Club and they organise all sorts of fun events from trips to the cinema, to cycling the Greenway, to climbing the Wibit in Dunmore and everything else in between!
  • Let them eat cake we say! Any excuse for cake and we’re on it
  • We like healthy stuff too, sometimes we even have salads with our Free Food Friday lunches
  • We host all sorts of fun events to help raise money for our employee chosen charities – this even includes doing a spinning class!

What will you get if you work with us?

Aside from having a great day at work, you’ll also get:

  • A great work environment with lots of fun
  • A chance to work with like-minded people
  • Be part of a team of people who work together to make life-saving products
  • Work in Ireland’s Pharma Company (SME) of the Year
  • A great financial package to meet your knowledge and experience
  • A company contributed pension
  • Health Insurance
  • Extra day’s holidays
  • Company sponsored events and nights out
  • And lots of other stuff!!

 We are a rapidly growing pharmaceutical company and we need more great people to join our team to keep growing at this speed! We pride ourselves in recruiting, developing, and retaining the best people.

Want to be a part of all of this? Then send your CV to HR@EirGen.com to apply for our R&D Analytical Development Chemist role today and become a fellow EirGener!!

 

CLICK TO APPLY

eSystems Compliance Officer

We are recruiting for an eSystems Compliance Officer to join our expanding Quality Systems Team.  This person will assist team(s) in the preparation of validation related documentation, standard operating procedures, reports, system quality reviews, identifying deficiencies, preparing CAPA documents, test scripts and change controls with regards to automated systems validation. Also to ensure that site automated systems are introduced, maintained and operating in accordance with cGMP’s, site and corporate policies and regulatory requirements with a keen focus on Data Integrity. The ideal candidate will have a Relevant degree in pharmaceutical science, quality management, computer science, computer engineering, life science, or any other pertinent degree, at least 3 years experience in pharmaceutical industry, within a quality or IT function and In-depth knowledge of FDA and European compliance regulations and GAMP guidelines applicable to computer system validation. The role offers a competitive salary with benefits package and a great place to work!

CLICK TO APPLY

MAINTENANCE TECHNICIAN – FACILITIES

We are seeking a Maintenance Technician – Facilities to ensure equipment is maintained to the highest standards possible through systematic predictive maintenance, preventative maintenance and repairs. The role includes:

  1. Supporting the Operations Team in the reliable operation of their equipment.
  2. Developing predictive maintenance methodologies.
  3. Producing preventative maintenance routines based on RCM methodologies.
  4. Effective problem solving and reactive maintenance as required.
  5. Ensuring the preventative maintenance routines are executed on time and in a compliant manner.
  6. Maintaining and operating Facilities/Utility equipment
  7. Continuously improving the process through the improvement of equipment performance.
  8. Supporting project activities as required to ensure maintenance and operational requirements are included. FAT attendance, commissioning and qualification support. Procedure and Maintenance schedule development for new assets.

We welcome applications from persons who meet the following criteria:

  1. Senior trades and/or a relevant third level qualification in Electrical, Mechanical or Manufacturing discipline.
  2. Minimum 5 years’ engineering experience within a relevant environment (preferably within a Pharma manufacturing environment)
  3. Experience in a sterile Manufacturing environment would be an advantage.

 

 

CLICK TO APPLY

PROCESS SCIENTIST

We are seeking an experienced Process Scientist to join our Technical Services team. This person will ensure process validation activities at EirGen Pharma are completed in line with internal and regulatory procedures and guidelines.  All applicants must have the following criteria:

  • Degree in an engineering or science discipline.
  • Experience and knowledge of any or all of the following is desirable:
    • Statistical packages, e.g. Minitab
    • Analytical techniques
    • Process validation
    • Pharmaceutical solid dose manufacturing
    • Execute protocols and reports for the validation of new and existing processes

If you match the above criteria and are looking to join a rapidly growing pharmaceutical company who takes pride in its employees. Click below to apply now!

CLICK TO APPLY

PROCESS VALIDATION ENGINEER (Junior)

We are seeking a Process Validation Engineer to ensure process validation activities at EirGen Pharma are completed in line with internal and regulatory procedures and guidelines.  We welcome applications from persons who are qualified to a Degree level  in an Engineering/Science discipline and with at least 2 year relevant experience ideally with Process Validation and Statistical packages. This job offers competitive salary and benefits.

CLICK TO APPLY

IT BUSINESS SYSTEMS ANALYST

We are looking for IT Business Systems Analyst to join our expanding IT team. This person will be responsible for all IT and system support company wide within EirGen and will ensure that all information systems are maintained to the required regulatory and best practice standards, ensuring business continuity. This successful candidate will have minimum of degree level in Computer Systems or IT related discipline and at least 4 years’ experience in pharmaceutical or regulated environment/industry. Click below to Apply now!

CLICK TO APPLY

QUALITY SYSTEMS CONTROLLER

We are recruiting for a Quality Systems Controller to join our expanding Quality Systems Team.  The primary role of a quality systems officer is to ensure that all quality systems are maintained in compliance with company, regulatory and health & safety requirements.  The applicant should have a relevant third level degree qualification with 2 years experience in a similar role. The role offers a competitive salary with benefits package and a great place to work! Click to Apply now!

CLICK TO APPLY

R&D STERILE PROCESS LEAD

We have an exciting opportunity for an R&D Sterile Process Lead to join our growing R&D Team. The R&D Sterile Process Lead will be responsible for supporting the R&D Department by providing significant fill-finish technical expertise to support all aspects of the manufacturing of sterile products. As a key member of the R&D Team, this role will provide leadership, cross-functional development, and technical expertise on the aseptic manufacture of biologics. We welcome applications from candidates who are qualified to a minimum of degree level in an appropriate science or engineering discipline, preferably biotechnology. The ideal candidate would have at least five years’ experience working in relevant unit operations including mixing, formulation, sterile filtration, sterilisation, aseptic processing, component processing technologies, liquid filling, and visual inspection.

CLICK TO APPLY

PROCESS ENGINEER – LYOPHILISATION

We have an exciting opportunity for a Lyophilisation Process Engineer to join our expanding Engineering team, to support the OPKO R&D project in the delivery, installation, commissioning, qualification and cycle development of the IMA Lyofast 5 Freeze Drier. We welcome applications from candidates who hold a minimum degree level qualification in engineering and who have a minimum of 15 years’ experience in Freeze Dryers, Autoclave; Steam in Place (SIP) / Clean in Place (CIP) skids. Experience with commissioning, and validation of Lyophilisation equipment is also essential.

CLICK TO APPLY

CALIBRATION & INSTRUMENTATION TECHNICIAN

The Engineering Team at EirGen Pharma are recruiting for a Calibration & Instrumentation Technician to join their expanding team, to ensure equipment instrumentation is calibrated to meet engineering and GMP requirements and to support the operation and Maintenance of equipment as part of the Engineering Team.  Applicants should have a Senior Trades and / or a relevant third level qualification in Instrumentation, Electrical or related and have a minimum of 5 years instrumentation experience, preferably within a pharma manufacturing environment.   Experience in a sterile Manufacturing environment would be an advantage.

CLICK TO APPLY