About Your New Employer:
A clinical-stage genetic medicine start-up company with a broad pipeline of late-stage clinical programs supported by end-to-end manufacturing capabilities. The Employer offers the state-of-the-art production facilities as well as an in-house Quality Control hub for stability and release, all fit for IND through commercial supply.
They believe temporal control of genetic medicine products has the potential to transform the genetic medicine landscape.
About Your New Job as a QA Validation Engineer:
- Maintenance and archiving of Validation/Qualification documentation.
- Interface with other departments such as Engineering, QC Laboratories, Operations, Supply Chain and Process
Development to ensure that validation project plans are understood and adhered to. - Review and approve validation, qualification protocols and reports.
- Provide oversight to project-related Deviations.
- Maintain understanding of cGMP, Good Engineering Practices and guidance in relation to all aspects of
validation across manufacturing, laboratories and facilities. - Support generation of Process and QC Equipment Installation, and Operational and Performance
Qualifications, review and approve the Qualification protocols, discrepancies and reports for Quality. - Provide QA support to data integrity compliance activities across the site.
- Write or assist in writing of Policies, SOPs, work instructions and forms for validation requirements and other quality systems as required.
- Support Regulatory Inspections and third party audits
- Responsible for ensuring that any GMP documentation - Issues, CAPAs, Change Controls, BMRs & audit/inspection actions are closed timely and in a RFT state.
- Ensure validation of the processes and equipment meets applicable regulatory requirements for a new GMP
Gene Therapy manufacturing facility. - To effectively guide the implementation of the Site Validation Master Plan, working with the engineering,
operations and QC teams to oversee the commissioning; qualification and validation of the manufacturing
facility and supporting activities. - Participate in risk assessments to develop process validation plans and protocols with Development, Operations and QC staff.
What Skills You Need to succeed as a QA Validation Engineer:
- BSC in Science / Engineering
- Strong Quality Assurance background working in a Pharmaceutical or Biotech Production environment within
sterile manufacturing. - Extensive experience with providing QA technical support and oversight to validation and qualification
activities and with implementing the concepts, legislation, guidelines and requirements related to qualification
and validation of sterile products, aseptic processes, equipment and systems, including Computer System
Validation e.g. EU/FDA GMP guidelines, EU Annex 15, PIC/S & GAMP guidelines, EU Annex 11 & CFR Part 11
and ICH Q9. - Knowledge of cell culture-based manufacturing techniques and requirements and cellular and gene therapies.
- Experience in using risk assessment tools including FMEA.
- Ability to balance needs of the business with the needs of the Regulatory challenges.
- Proven ability to work successfully in an ambitious, deadline-driven environment and handle multiple tasks
simultaneously
What’s on Offer for Candidates for QA Validation Engineer role:
- Salary 70k - 75k
- Excellent benefits package – pension, health insurance including dental, life assurance, 25 days AL, share options and more
- Fantastic career development opportunities
What’s Next
- Apply now by clicking the “Apply Now" button, call Karolina on +353 091749267 or send your CV directly to kjaglowska@sigmar.ie
- Or if the job isn’t quite right but you are looking for something similar, please get in touch. We also have multiple Temp, FTC and Contract jobs available.
