- A new opportunity has arisen for a Validation Engineer at our client’s biopharmaceutical facility in Co. Waterford.
- The purpose of this position is to be the subject matter expert in the client’s Fill Finish validation operation and be a recognised expert in this industry.
- S/he will design, coordinate and execute validation activities in support of the start-up of the manufacturing facility, and will be responsible for on-going re-validation of equipment and processes.
Core Duties and Responsibilities:
- Develops and writes commissioning, qualification and validation documents following established standards and templates, including but not limited to the following:
- Commissioning Test Scripts
- Qualification / Validation Protocols and Summary Reports
- Standard Operating Procedures
- Risk Assessments
- Specifications (URS)
- Trace Matrix (TM’s) / Reliability Trace Matrix (RTM’S)
- FATs / SATs
- Performs and assists with execution of validation protocols (IQ, OQ, PQ) associated with the start-up, and with the on-going re-validation of equipment and processes.
- Analyse analytical and in-process data for statistical control
- Present validation approach and study results to peers and managers
- Performs walk-down and verification of system drawings (i.e., P&IDs, as-builts, etc)
- Management of the development and execution of IQ, OQ and PQ activities.
- Ensures projects are managed in conjunction with all company and regulatory requirements (Health & Safety, cGMP, construction, environmental etc).
- Provide technical assistance on current US FDA and EU validation requirements for aseptic processing and sterilisation.
- Ensure that the validation status of equipment and systems are compliant to cGMP.
- Present and defend validation studies during regulatory inspections
- Management of validation documentation through:
- Approval and implementation of changes to relevant systems and assist in generating validation/ revalidation plans
- Review/approve execution of the validation/revalidation plans
- Responsible for review of all design deliverables from the Engineer including drawings, datasheets, specifications and engineering lists.
- Point person for review for all associated vendor packages.
- Liaise with Engineers in relation to construction readiness and a schedule for systems/equipment within areas of responsibility
Qualifications and Experience:
- Bachelor’s degree (or equivalent) in Science (Chemistry, Microbiology, or Pharmacy preferred) or Engineering (Chemical/Mechanical).
- Further qualifications (e.g. Masters) preferred.
- At least 12+ years relevant experience in a pharmaceutical manufacturing environment, with at least 6+ years’ experience in a comparable Validation Engineering role.
- Must have experience working in a sterile manufacturing environment.
- Requires prior experience performing validations of multiple systems and equipment in a time-sensitive start-up program.
- Strong technical knowledge of aseptic manufacturing techniques.
- Knowledge of requirements for design, installation, commissioning, qualification and validation of pharmaceutical equipment, systems and utilities using risk-based approaches.
- Knowledge of leveraging test data from early-stage project testing into later stages (e.g. FAT into SAT/IOQ).
- Knowledge of regulatory validation requirements including FDA, EMA and all other applicable worldwide Regulatory requirements (ICH Q7, Q8, Q9).
- Computer skills (Spreadsheets, Word Processing, Visio, Microsoft Project).
- Strong analytical skills, documentation skills and research skills.
- Very strong problem-solving skills, ideally using formal tools e.g. FMEA.
- Ability to effectively prioritise and manage a diversified workload, often to tight deadlines.
- Strong understanding of pharmaceutical industry regulatory requirements.
- Strong communication and interpersonal skills, a professional approach with excellent written and verbal communication skills. Highly motivated with ability to work effectively with multidisciplinary teams or independently.
- Strong team player.
- Knowledge and capability to perform validations of automated systems.
- The role will typically require infrequent, off site national and international travel, for business or equipment/project review meetings, including overnight stays, up to 10% of the time.
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
14 Danville Business Park, Kilkenny, Ireland
+353 56 77 90100
Please note, we do not require agency assistance with this role.