On behalf of our client, a global leader with a mature biologics portfolio, located in Alsace (FR) close to the Swiss border, we are looking for a
The (Senior) Process Validation Expert will define and implement process validation activities linked to biologics drug substance manufacturing at the site. This includes process validation studies (e.g., validation of process unit operations, holding times, lifecycle studies) and also related systems (e.g., cleaning, site risk management). He/she will (be in charge of) support definition of study strategy, planning, and activity coordination, writing and approving documents related to these activities, and communicating progress to site and network management.
He/She will be required to work in close collaboration with Process Development, Engineering, Production, Supply Chain, Quality, Regulatory departments, and with other manufacturing sites within the corporate network, to ensure quality, on-time supply of our products to our patients.
Validation Expert (Senior Validation Expert)
- (Lead)/support creation and maintenance of the Validation Master Plan (VMP) for process and/or site manufacturing systems (e.g., cleaning validation).
- (Lead)/participate in the definition of concepts and requirements for process validation in collaboration with internal and external process experts, in accordance with Quality Assurance (QA) and regulatory prerequisites.
- Set local procedures, templates, and evaluations/risk assessments for validation processes, documentation and validation master plans.
- Provide guidance to the manufacturing site on the impact of component criticality assessments. Be responsible for translating the process control strategy into a focused plan for process validation and maintaining this throughout the product lifecycle.
- (Lead)/support the strategy for ongoing (continued) process verification (OPV). (Lead)/contribute to risk assessments for OPV.
- (Lead)/support the strategy for cleaning processes validation and extractables and leachables studies. Support writing and approval of validation documents.
- Execute and manage the validation plan according to priorities defined in the plan.
- Maintain all responsible activities and projects in an inspection ready status ahead of any internal or external audits to ensure successful inspections, e.g., no critical observations related to validation activities.
- Support/(lead) troubleshooting of complex validation relevant issues during manufacturing operations. Support/(lead/coordinate) investigation teams.
- Lead/(support) deviation management and Change Control management. (Ensure appropriate stakeholder engagement and support, and clearly communicate on progress and issues).
- Support validation strategy alignment team including partners from different manufacturing sites (internal/external) and global functions.
- Maintain knowledge of regulatory requirements as defined by EMA, FDA, and ICH Guidance Documents. Review technical publications to stay abreast of technical developments in industry. (Proactively share and stimulate knowledge sharing within site and wider drug substance manufacturing and development network).
- Develop and write responses for technical sections of Regulatory documents.
- Write (review and approve) CMC sections for regulatory filing documents and responses to questions from Regulatory Agencies. (Provide guidance to team on appropriate content).
- Represent the Process Validation team during regulatory and routine compliance audits/inspections.
If this challenge appeals to you, please do not hesitate to apply, through our online portal or via mail. All applications will be treated in strictest confidence and all applicants will receive a response. For any further questions, please contact Dr. Stefanie Malki (email@example.com).