A Validation Engineer (Sustainability)
This position is responsible for the execution, project management, review and approval of validation activities in a GMP regulated environment, focused on implementation of new manufacturing processes, equipment, computer systems, laboratory systems and changes to existing equipment.
- Provide quality and project management oversight for review and approval of Qualification and Validation of Facilities, Utilities & Equipment (FUE) activities related to company's products. Project lifecycle documentation e.g. URS, Commissioning/ Qualification Protocols, GMP Risk Assessments, Design Specifications, Functional Specifications, Installation Qualification, Operational Qualification, Performance Qualification, respective protocols and reports, supporting site discrepancies/deviations, investigation and closure in line with company quality standard and site procedures, etc.
- Responsible for delivering the Revalidation program (RVE) requirements as per the RVE schedule.
- Coordinate and communicate revalidation activities involving cross-functional, multi-departmental teams including: Engineering, Manufacturing, Process Sciences, Quality Control, Quality Assurance, Regulatory Affairs, etc.
- RVE responsibilities include the following: performance of detailed system review, generation of RVE documentation, scheduling & coordination of each RVE, performing and/or coordinating revalidation testing, completion of validation documents, etc.
- Assess the impact of changes to the validated state of systems/equipment as part of the site change control program (e.g. system implementation projects /system modifications, etc.) and Trackwise deviations. Demonstrate a robust understanding of Change Control process; appreciating wider implications to site beyond immediate requirement
- Identify, track and resolve issues through robust root cause analysis in a timely manner working with relevant SMEs as required. Apply a risk management approach to identify, categorise, prioritise, mitigate and establish contingency plans associated with qualification / validation and system risks
- Maintain current knowledge of industry standards and regulatory requirements and trends for products developed or manufactured by the company, validation techniques/approaches and systems utilized.
- Lead and represent validation in multi-departmental meetings & project teams.
- Identify and implement improvements to the QA Validation systems.
- Demonstrate the ability to exercising judgment within broadly defined procedures and practices to establish approval criteria and identify and implement solutions.
- Bachelor of Sciences degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required.
- +5 years' experience in a cGMP regulated manufacturing environment, with knowledge of Facility, Equipment and Utility validation and Laboratory Systems validation.
- Experience in a number of the following areas would be desirable: Cleaning Validation, Sterilisation, Temperature Mapping, Packaging Validation, etc. Computer Systems Validation experience would be an advantage.
- Organizational and management skills to coordinate multi-discipline project groups
- Demonstrated ability to speak, present data, and defend approaches in front of audiences and inspectors.
- Demonstrated ability to comprehend technical information related to equipment, processes, and regulatory expectations.
- Experience with participation in regulatory inspections presenting or defending departmental functions in audits or regulatory inspections.
- Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for equipment validation expectations.
- Proficiency in use of risk assessment and problem-solving tools to contribute, as a technical resource, to Quality / Compliance-related investigations.
- Proficiency with technical summary report generation required, with exceptional organizational, spelling, grammar, and typing skills preferred.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
Fastnet - The Talent Group
'Not Just Placers.........Partners'
The Life Science Specialists