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.

QC CHEMIST

We have an exciting opportunity for TWO QC and Stability Chemists to join our team, you will support the QC and Stability by ensuring all raw materials, packaging, finished products and Stability samples are analysed in accordance with cGxP. You must be minimum of degree qualified in Analytical Chemistry, Pharmaceutical science or related discipline, along with having two years’ experience working in a related technical environment. A competitive salary including an attractive benefits package is on offer for the right candidates. 

If you match all the above criteria and want to join the Pharma Company of the Year – SME 2017, click below to apply! 

CLICK TO APPLY

QUALITY ASSURANCE OFFICER

We are looking for an experienced Quality Assurance Officer to join our wonderful QA Team. This person will support the QA Manager with the development, implementation and maintenance of EirGen quality standards and systems to ensure that products comply with Marketing Authorisations, documentation, specifications and cGMPs.

If you are qualified to a degree level preferably a Science degree incorporating QA  and have at least two years’ experience working in a QA role in a manufacturing environment.

We want to hear from you!

CLICK TO APPLY

 

REGULATORY AFFAIRS OFFICER

JOB SUMMARY

Location: EirGen Pharma, Waterford

Title: Regulatory Affairs Officer

Reporting to: Senior Regulatory Affairs Officer

 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!

If you match all the above criteria and want to join the Pharma Company of the Year – SME 2017, click below to apply! 

CLICK TO APPLY

REGULATORY AFFAIRS CONTROLLER

EirGen Pharma have a vacancy for Regulatory Affairs Controller to join their growing Team! This role will support the Regulatory Affairs Manager and Regulatory Affairs Officers with activities associated with the registration of EirGen’s/OPKO’s products in Worldwide markets including US, EU and Japan, as well as Regulatory compliance liaison with QA and Compliance for registered products. This role would suit someone with at least 12 months’ experience working in a GMP environment or relevant administrative experience, including being competent in the use of Microsoft Word, Excel, and Project.

If you match all the above criteria and want to join the Pharma Company of the Year – SME 2017, click below to apply!

 

CLICK TO APPLY

PROCESS LEAD – STERILE

JOB SUMMARY

Location: EirGen Pharma R&D Centre, Waterford

Title: Process Lead – Sterile

Reporting to: Head of R&D and based at our R&D Centre on the Cork Road

 Why is this role open?

EirGen Pharma have a new vacancy for an Process Lead – Sterile which sits within the Research & Development team who have just moved into a state of the art sterile fill finish site and are in the process of working with a new line of products. The role is to provide scientific/engineering leadership across all the disciplines involved in Technology Transfer and Sterile Operations.  This role would suit candidates with biotechnology academic attainments, at least 5 years’ experience in working within sterile operations/tech transfer and fill finish manufacturing.

What will you be doing?

  • Provide scientific/engineering leadership across all the disciplines involved in Technology Transfer and Sterile Operations
  • SME for introduction of single use systems and assessment of their use in terms of extractables, leachables and container closure
  • SME for sterile formulation of biologic products
  • Support all aspects of the manufacturing process from formulation and filling to visual inspection
  • Technical review of change controls for impact to product quality, safety and efficacy
  • Provide on-floor technical support and troubleshooting
  • Identify and then lead process optimization initiatives and address opportunities for efficiency and capacity improvements in all areas of manufacturing
  • Technical protocol and summary report generation as related to technical studies executed in direct support of GMP manufacturing activities
  • Collection, organisation, trending, and analysis of GMP manufacturing data
  • Identify manufacturing best practices across the network and lead or participate in teams to implement best practices
  • Provide SME input for IND, BLA and other technical documents for regulatory agency submission in support of manufacturing process
  • Assist the team with development of objectives and ensures alignment with site goals
  • Assist the Program Lead to generate and execute a Technology Transfer Master Plan
  • Responsible for ensuring availability of knowledge, information, expertise and training as needed for the activities necessary to execute the transfer and all testing to support the Technology Transfer process, as relevant to the Receiving Unit
  • In association with the Sending unit Technical lead define the risks, gaps and closure plans
  • Lead the pre-GMP line activities (Development, Pre-Eng, Eng Run, as applicable) along with all associated protocols and reports
  • Ensure information transfer to Process Engineering group for all cycle development activities
  • Review sampling plans for all activities and ensure compliance with all TT requirements
  • Support the generation of the Control Strategy
  • Ensure appropriate scientific and engineering documentation is collated and approved for a robust Process Flow document
  • Ensuring that operational modifications or processing gaps are identified and updated in the operational control strategy.

 

What we need from YOU:

  • You MUST be passionate about Process, Tech Transfer and Biopharma
  • An honours degree in Science/Biotechnology (or a related discipline)
  • You MUST have at least 5+ years’ experience in the following areas:
    • mixing, formulation, sterile filtration, sterilisation, aseptic processing, component processing technologies, liquid filling and visual inspection.
  • Significant exposure to sterile operations and/or Tech Transfer projects
  • Experience in fill-finish process development and/or manufacturing support with extensive practical knowledge of liquid fill operations.
  • Comprehensive understanding of cGMP requirements for clinical and commercial biopharmaceutical manufacturing and the ability to implement best practices
  • Experience of technology transfers and implementing new clinical and commercial biopharmaceutical manufacturing processes, specifically sterile liquid fill operations.
  • Familiarity with protein handling and processing considerations and how operating conditions can impact Critical Quality Attributes.
  • Self-starter who enjoys working in a fast paced environment
  • You MUST enjoy working as part of a team and be fun and friendly

If you match all the above criteria and want to join the Pharma Company of the Year – SME 2017, click below to apply!

CLICK TO APPLY

PRINCIPAL SCIENTIST – LYOPHILISATION 

JOB SUMMARY

Location: EirGen Pharma R&D Centre, Waterford

Title: Principal Scientist – Lyophilisation

Reporting to: Head of R&D and based at our R&D Centre on the Cork Road

 

Why is this role open?

EirGen Pharma have a new vacancy for an Lyophilisation Scientist which sits within the Research & Development team who have just moved into a state of the art sterile fill finish site and are in the process of working with a new line of products. The role is to support the design and scale-up of lyophilisation processes suitable for clinical production, including cycle optimization, robustness studies, and technology transfer.  Candidates should have biotechnology educational attainments, a minimum of five years’ experience within the pharmaceutical industry, preferably in a Biopharma role with significant exposure to Lyophilisation & cycle development, and have ideally worked within an aseptic fill finish environment.

What will you be doing?

  • Advise on lyophilisation cycle development, optimization, scale up and Technology Transfer of finished products using state of the art techniques
  • Design and execute accelerated stability testing plans that demonstrate suitability of Lyophilised formulations
  • Complete required batch documentation records with accuracy and legibility
  • Ensure product quality by performing in-process checks, complying with current good manufacturing practices
  • Track and report deviations to a process, initiating quality improvements and participating on quality improvement projects as required.
  • Act as R&D liaison between relevant Managers, Q A, Research, Tech Services, Engineers and Maintenance personnel in all matters regarding freeze drying
  • Participate on manufacturing project teams to assist with cycle development through collaboration with R&D.
  • Review work scope, rationale, approvals, changes to appropriate equipment/systems and re-qualification activities
  • Assist in the training of sterile operators or cross-training in other areas.
  • Troubleshoot and perform adjustments on equipment as required.
  • Ensure that all work is carried out in compliance with the required standards to conform to company, cGxP, health and safety, environmental and regulatory requirements.

 

What we need from YOU:

  • You MUST be passionate about Lyophilisation and Biopharma
  • An honours degree in Science/Biotechnology (or a related discipline)
  • You MUST have at least 5+ years’ experience
  • Significant exposure to Lyophilisation & cycle development
  • Ideally have worked within an aseptic fill finish environment
  • Demonstrated knowledge in pharmaceutical / biopharmaceutical technical / manufacturing operations.
  • Self-starter who enjoys working in a fast paced environment
  • You MUST enjoy working as part of a team and be fun and friendly

If you match all the above criteria and want to join the Pharma Company of the Year – SME 2017, click below to apply!

CLICK TO APPLY

QC & STABILITY DATA REVIEWER

We are looking for a  QC and Commercial Stability Data Reviewer to join our Team. This person will support Product Development and Commercial Supply by ensuring all components, raw materials, finished products and Stability are tested in accordance with cGxP.

Some Responsibilities include:

    1. To review raw data from testing of components/raw materials/finished products and stability in a timely & efficient manner.
    2. To manage and control all raw data presented for review and file once completed.
    3. To complete required release documentation including commercial stability summary sheets.
    4. Trending of finished product and API testing.
    5. Complete investigations in a timely and efficient manner where applicable.

We are looking for someone who is qualified to a minimum of degree level and has at least two years experience working in a related technical environment.

 

CLICK TO APPLY

EQUIPMENT VALIDATION ENGINEER

Our Engineering Team have a NEW vacancy for an Equipment Validation Engineer to join their rapidly growing team. Reporting directly to the Equipment Validation Team Leader, this role will be responsible for equipment validation in Sterile Fill Finish to ensure the maximum levels of performance and compliance are maintained. The ideal candidate will be qualified to a minimum of higher degree level in Engineering or a related discipline and will have at least 3 years’ validation engineering experience within the pharmaceutical environment, preferably within a sterile manufacturing environment.

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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

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.

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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