What you need to know
We are currently seeking a Validation Engineer for our biopharmaceutical client, based in Waterford.
This is an excellent opportunity to join a dynamic team during an exciting growth phase.
This is a permanent role with an excellent salary and benefits package on offer.
Your new job
Key duties & responsibilities:Develops and writes commissioning, qualification and validation documents following established standards and templates
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
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
What are we looking for?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.
Strong understanding of pharmaceutical industry regulatory requirements.
Strong communication and interpersonal 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.
Please apply using a CV in Microsoft Word format, thank you.
Please note that due to the expected high volume of applications we can only reply to applicants suitable for the position. In the interest of protecting your data and informing you of your rights we will notify you should we retain your information by issuing an acknowledgement email and a request for consent where not already expressly given.