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.

QA TEAM LEAD

QA Team Lead

 Who We Are

We’re a world-leader in the development, registration, manufacture and supply of high-potency pharmaceutical products to global markets. Based in Waterford, Ireland, we are a leading pharmaceutical company that utilise state-of-the-art high containment facilities to develop and supply life-saving medicines all over the world. We’re passionate about what we do.

Our Vision is to produce innovative, patient-centred solutions as the research & development and supply chain centre of excellence for OPKO.

The EirGen Way

This is the value we place on the fun, informal work environment, and the innovative and supportive people that make up our team. We’re proud of our company, and passionate about enhancing and improving our patients lives;  A lot done, a lot more to do

Are You Exceptional?

We’re on the hunt for an experienced QA Team Lead who will bring brilliance to our QA Department. Someone who has a highly motivated with a mindset that is wired with a team-first attitude, has no problem rolling up their sleeves to execute their missions, and can shift between leading and following as needed.

What You’ll Be Doing

You will support QA Manager and Head of Quality with the development, implementation and maintenance of EirGen quality standards and systems to ensure that products comply with Marketing Authorisations, documentation, specifications and cGMPs. You will lead and develop EirGen’s group of Quality Assurance Officers, within commercial batch release team.

Other duties include (but not limited to)

  • Ensuring project plans and milestones are delivered to agreed timelines
  • Ensuring product are released in timely manner
  • Commercial Manufacture: Provide direct and plan work schedule for your team
  • Compliance
  • Continuous Improvement,
  • Documentation
  • Recruitment/ Coaching / Mentoring

What we need from YOU:

  • Qualified to a minimum of Masters level, preferably a Science degree incorporating QA.
  • Five years’ experience working in a QA role in a manufacturing environment
  • Experience in managing a team
  • The following would be an advantage: QP qualification, Experience of batch release, Lead Auditor and Supervisory Management.

Come join us on this incredible journey!

SUPPLY CHAIN CONTROLLER

We have an exciting opportunity for a Supply Chain Controller to join our team on a 12 month contract basis. This person will be the administrative support for the supply chain department. The ideal candidate will have a third level qualification and at least 2 years’ experience working in a regulated environment. A knowledge of SAP would be an advantage.

If you are interested in joining a dynamic, rapidly growing, and exciting company and have the necessary experience, then we want to hear from you!

Click below to apply or email your CV to HR@EirGen.com

CLICK TO APPLY

CLINICAL MANAGER

EirGen Pharma are currently seeking a Clinical Manager to join our expanding Scientific Affairs team. Our R&D pipeline includes not only generic drug developments but also new drug developments including paediatric medicines and innovative technologies in modified release and liquid fill capsule technologies to service both human and veterinary markets. The successful candidate will work closely with the Veterinary Clinical Manager to manage the various clinical programs to support these pipeline projects. The primary skills set requirement is in the management of the various types of PK studies required to bring both genetics and new drugs to market. A strong knowledge of ICH GCP is required.

If you are interested in joining a dynamic, rapidly growing, and exciting company and have the necessary experience and enthusiasm to meet the needs of this challenging role, then we want to hear from you!!

Click below to apply or email your CV to HR@EirGen.com

 

CLICK TO APPLY

TECHNICAL SERVICES ANALYTICAL TEAM LEAD

We have an exciting opportunity for a Technical Services Analytical Team Lead to join our Team. The successful candidate will organise the execution of Tech Services Analytical activities in line with department and company requirements and have responsibility for a Team of Chemists. All applicants must have a relevant third level qualification and at least 5 years previous relevant experience.  If you match all the above criteria and want to join the Pharma Company of the Year – SME 2017, click below to apply! 

A competitive salary including an attractive benefits package is on offer for the right candidate. 

CLICK TO APPLY

PROGRAMME MANAGER -PMO

We have a NEW opportunity for a Programme Manager – PMO to join our growing team! The purpose of this role is to lead groups of inter-related projects as an integral part of the EirGen Project Management Office (PMO) under the direction of the Head of Scientific Affairs. The ideal candidate for this role would have at least 5 years’ experience within a related industry, preferably in a project management role. A third level technical qualification would be highly desirable as would Project Management qualifications. This role would suit someone who has a proven track record of leading cross functional project teams.

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

R&D STERILE PROCESS LEAD

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

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.

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

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