Senior CQV Engineer
We are seeking a senior engineer with expertise in integrated risk-based commissioning and qualification approaches, experience in highly regulated environments, and knowledge of pharmaceutical and biotechnology industries, particularly in sterile drug product production.
Key Responsibilities:
* Strong experience with Validation Master Plan, Commissioning Master Plan, project procedures, and commissioning and qualification protocols (SAT/Commissioning, IQ and OQ).
* Plan, coordinate, and execute validation activities for sterile fill finish processes and equipment, ensuring compliance with regulatory guidelines (FDA, EMA, or equivalent) and company standards.
* Develop and review validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), ensuring they align with regulatory requirements.
* Strong knowledge of risk-based C&Q strategies, including ASTM 2500E and ISPE Baseline Guide Rev. 2.
* Familiarity with latest aseptic requirements, including Annex 1.
* Collaborate with internal stakeholders to ensure validation activities are properly coordinated and executed.
* Review and follow-up technical documentation from the early design phase to ensure alignment with GMP and CQV requirements.
* Schedule preparation and progress review, including coordination and review of daily qualifications tasks associated with projects.
* Analyze validation data and generate comprehensive reports with clear conclusions and recommendations.
* Stay updated with industry trends, regulatory requirements, and best practices related to fill finish equipment/systems validation.
* Collaborate with vendors and suppliers to ensure proper installation, qualification, and maintenance of fill finish equipment.
* Lead and direct CQV teams during document creation and execution.
Requirements:
* 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.
* Experience with validation activities, including risk assessments, protocol development, execution, and report writing.
* Excellent problem-solving skills and ability to analyze complex data sets.
* Strong attention to detail and ability to work in a regulated environment.
* Effective communication and interpersonal skills to collaborate with cross-functional teams and stakeholders.
* Familiarity with quality management systems (e.g., ISO 13485, cGMP) and their application in laboratory operations.
* Ability to manage multiple projects simultaneously and prioritize tasks effectively.
* Experience with Kneat GX digital validation tool is advantageous.