Senior Manufacturing Specialist

Purpose Statement
Ensure operational efficiency and compliance by managing technical documentation, addressing non-conformances, and implementing corrective actions.
Streamline processes and drive continuous improvement across manufacturing operations.
Effective change management, thereby fostering process enhancements and ensuring compliance with regulatory standards.
Operations and Technical
Conduct technical writing and collaborate with Operations and cross-functional team to investigate non-conformance issues.
Develop and implement corrective and preventive measures together with the Operations team and cross-functional team.
Manage change processes to enhance operations.
Develop and conduct training modules for Operations and new employee onboarding.
Analyze key performance indicators and execute strategies to optimize workflows.
Author and revise GMP-related documents.
Collaborate on the creation, revision, and enhancement of electronic batch records.
Lead or participate in projects aimed at enhancing operations or new product introduction.
Utilize quality management systems and operations-related software, such as Trackwise, LIMS, SAP, POMSnet, Delta-V or others.
Prepare and support regulatory inspections and internal audit.
Engage in projects aimed at continuous operational improvement.
Engage in regular GEMBA walkdowns.
Organize regular meetings with cross-functional teams to discuss and update daily operational matters.
Safety
Ensures a safe work environment by adhering to regulatory and global/local Environmental, Health, and Safety (EHS) policies.
Quality
Ensure investigations are conducted and completed promptly and to a high standard.
Ensure that process improvements are relevant and beneficial to the manufacturing operations.
Verify the accuracy of impact assessments and ensure corrective and preventive actions are relevant.
Serve as point of contact for change management documentation and investigations during audits and inspections.
Schedule
Strive to complete investigations in a timely manner to minimize any potential impact on batch release timelines or shipment schedules.
Ensure that process improvement changes are executed on schedule as planned for the production run.
Master or Degree with at least 5-7 years relevant experience in Biologics Production facility, or
equivalent.
Good working knowledge of cGMP and regulatory requirements related to Manufacturing is preferred.
Strong working knowledge of GMP systems such as Trackwise, SAP, LIMS, MES systems are preferred.
Experience with cGMP documentation and record maintenance.
Experience with Regulatory inspections is required.
Strong ability to lead and drive cross-functional teams.
Possesses a positive work attitude and a strong determination to complete tasks efficiently.
Agility, capable of performing under pressure, and able to address various priorities.
Good presentation and strong technical writing skills.

Employment type
Full-time

Work arrangement
No