Validation Engineer IV - Contractor - Katalyst Healthcares & Life Sciences
Hopewell, NJ 07080
About the Job
Responsibilities:
- Develop and approve cGMP documents including, but not limited to: Equipment and instrument Qualification, Commissioning, Master Validation Plans, SOP's, Comparability reports, Aseptic Process simulation protocols and reports; process validation (PPQ), and cleaning/sterilization validation.
- Lead validation activities for project activities including review of validation documentation and attendance at validation activities (FAT, SAT, IQ, OQ, PQ) etc.
- Ensuring that the Validation department meets or improves key performance indicators (KPIs). Works to ensure all validation projects are on time and on budget. Ensures adequate validation resources. May manage validation consultants on a large project basis, as needed.
- Leading and Managing projects for the validation of equipment, processes, and products to meet all safety, quality, regulatory and operational requirements.
- Review of equipment specification/design/procurement/installation and validation.
- Project planning and execution including scheduling, task management, milestone planning and reporting.
- Generation, review, and approval of project documentation (User Requirement Specifications, validation protocols, reports) and Standard Operating Procedures
- Lead validation activities for project activities including review of validation documentation and attendance at validation activities (FAT, IQ, OQ, PQ, etc.).
- Employee will be required to work closely with both manufacturing, quality, and engineer associates.
- Maintaining the validation sample management, assessing the requirements for data acquisition, and coordinating validation projects.
- Ensuring appropriate investigation of validation discrepancies, errors, protocol failures, or validation testing errors requiring documented review and action to reconcile deviations.
- Position flows based on project needs up to and including quality approvals.
- Undertaking any other duties for any department within the business, which may be requested by the Line Manager, for which training and/or an explanation has been provided and understood.
- Scientific degree (ideally: pharmaceutical sciences, engineering, chemistry, or related discipline).
- Strong knowledge of cGMP's.
- Knowledgeable in risk assessments and process for following well documented and thought through risk-based approaches.
- Biotech and/or Sterile manufacturing and aseptic processing knowledge required.
- Experience in Computerized System Validation (CSV).
- Biopharma Process Experience
- Minimum of 10-15 years' experience in validation (with degree 10+: without 15+), biological quality assurance and/or quality control in an FDA-regulated biotechnology or pharmaceutical company with progressive levels of responsibility.
- Knowledge of cGMP's and Data Integrity principles.
- Demonstrable track record and skills/experience gained within a similar position(s), at a similar level. Good personal leadership.
- Good communicator (written and verbal) at all levels.
- Customer focused. Strong analytical and problem-solving ability.
- Hands-on approach, with a 'can do' attitude. Able to work under minimal or appropriate supervision level.
- Ability to prioritize, demonstrating good time management skills.
- Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
- Self-motivated, with the ability to work proactively using own initiative.
- Highly Desirable: Good IT skills e.g., Microsoft Office (Word, Excel, PowerPoint, Project and Outlook); working knowledge of SAP desirable but not required.
- Detail oriented individual must be able to work alone and complete tasks without requiring much supervision.
- Must be able to meet deadlines and produce quality work consistently.
- Engages in the day-to-day activities of the Validation function, ensuring the successful management of related activities and large projects.
- Supports Validation objectives, whilst adhering to regulatory compliance and achieving commercial success.
- This is a site-based position supporting the facility and will require gowning into the manufacturing suites. Bring equipment in/out of the cleanrooms as per procedure.
- Ensures the Validation function supports operational needs and ensures regulatory compliance requirements are met.
- CQV experience is a must and good understand Commissioning, Qualification, and Validation protocols and final reports. Able to write final reports and technical deviations, if needed during CQV execution.
- Skills Required:Validation protocols, Validation engineer, Regulatory compliance, Detail oriented.
Source : Katalyst Healthcares & Life Sciences