-
Job Description
Senior Engineer with expertise in integrated risk-based C&Q approaches to commissioning and qualification, with a focus on pharmaceutical and biotechnology industries.
The ideal candidate will have strong experience with Validation Master Plan, Commissioning Master Plan, project procedures and commissioning and qualification protocols, as well as a deep understanding of regulatory guidelines and company standards.
Key Responsibilities:
- Plan, coordinate, and execute validation activities for sterile fill finish processes and equipment, ensuring compliance with regulatory guidelines and company standards.
- Develop and review validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), ensuring they are comprehensive and aligned with regulatory requirements.
- Collaborate with internal stakeholders, including engineering, quality assurance, and operations teams, to ensure validation activities are properly coordinated and executed.
- Analyze validation data and generate comprehensive reports with clear conclusions and recommendations.
- Stay updated with the latest industry trends, regulatory requirements, and best practices related to fill finish equipment/systems validation.
Desired Skills & Experience:
- Proven experience in sterile fill finish operations, including isolators, filling machines, lyophilizers, autoclaves, and depyrogenation ovens within the pharmaceutical/biotechnology industry.
- Developed and executed process validation protocols for sterile fill finish processes, including aseptic filling, lyophilization, and terminal sterilization.
- Experience with re-qualification aspects of aseptic technologies, including media fill.
- Ability to contribute to or conduct contamination control risk assessments.
Requirements:
- Strong attention to detail and the ability to work in a regulated environment.
- Effective communication and interpersonal skills to collaborate with cross-functional teams and stakeholders.
- Ability to manage multiple projects simultaneously and prioritize tasks effectively.