About the role
We are looking for an experienced Production Engineer with a solid background in biopharmaceutical manufacturing. The ideal candidate is skilled in process validation, cGMP compliance, and continuous improvement within a regulated production environment.
Key responsibilities
Provide technical leadership for production systems, ensuring compliance with SOPs and regulatory standards.
Manage and revise SOPs, Batch Records, and related compliance documentation.
Investigate non-conformances lead CAPA and effectiveness check processes.
Perform periodic revalidation of batch records, utilities, and cleaning validation.
Initiate and manage Change Requests for continuous process improvements.
Oversee production scheduling, workforce planning, and shift operations.
Support IQ/OQ/PQ and requalification activities for critical equipment.
Act as SME during regulatory audits and support audit-readiness activities.
Lead Kaizen and Lean initiatives to dr...