Job Summary: We are seeking a senior CQV Engineer with expertise in integrated risk-based commissioning and qualification approaches, particularly in the pharmaceutical and biotechnology industries. The ideal candidate will have experience working in highly regulated environments and a strong understanding of regulatory guidelines.
">
Responsibilities:
">
">
* Commissioning and Qualification: Plan, coordinate, and execute validation activities for sterile fill finish processes and equipment, ensuring compliance with regulatory guidelines (such as FDA, EMA, or equivalent) and company standards.
">
* Protocol Development: 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.
">
* Risk-Based Strategies: Strong knowledge of risk based C&Q strategies including ASTM 2500E and ISPE baseline guide rev 2.
">
* Collaboration: Collaborate with internal stakeholders, including engineering, quality assurance, and operations teams, to ensure validation activities are properly coordinated and executed.
">
* Documentation: Review and follow-up technical documentation from the early design phase in order to ensure alignment with GMP and CQV requirements, including investigating and resolving technical issues.
">
* Data Analysis: Analyze validation data and generate comprehensive reports with clear conclusions and recommendations.
">
* Industry Trends: Stay updated with the latest industry trends, regulatory requirements, and best practices related to fill finish equipment/systems validation.
">
* Vendor Collaboration: Collaborate with vendors and suppliers to ensure the proper installation, qualification, and maintenance of fill finish equipment.
">
">
Requirements:
">
">
* Sterile Fill Finish Experience: Proven experience in sterile fill finish operations, including but not limited to isolators, filling machines, lyophilizers, autoclaves, and depyrogenation ovens within the pharmaceutical/biotechnology industry.
">
* Process Validation: Developed and executed process validation protocols for sterile fill finish processes, including aseptic filling, lyophilization, and terminal sterilization.
">
* Re-Qualification: Experience with re-qualification aspects of aseptic technologies, including media fill.
">
* Contamination Control: Ability to contribute to or conduct contamination control risk assessments.
">
* Validation Activities: Experience with validation activities, including risk assessments, protocol development, execution, and report writing.
">
* Problem-Solving Skills: Excellent problem-solving skills and the ability to analyze complex data sets.
">
* Regulated Environment: Strong attention to detail and the ability to work in a regulated environment.
">
* Communication Skills: Effective communication and interpersonal skills to collaborate with cross-functional teams and stakeholders.
">
* Quality Management: Familiarity with quality management systems (e.g., ISO 13485, cGMP) and their application in laboratory operations.
">
* Project Management: Ability to manage multiple projects simultaneously and prioritize tasks effectively.
">
* Digital Validation Tools: Experience with Kneat GX digital validation tool would be advantageous.
">