Job Description
Our client is currently looking for a senior engineer with a focus on utilizing integrated risk-based C&Q approaches to commissioning and qualification, have prior experience in highly regulated environments, and experience in the qualification of pharmaceutical and biotechnology industries, particularly in the production of sterile drug products The role will involve working with the C&Q Manager in supporting new and existing opportunities within the organization and be a key member as part of a core C&Q team centered around digitization of C&Q activities while bringing efficiencies to the process and maintaining compliance at all times. The ideal candidate should have following skills: 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 (such as 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 are comprehensive and aligned with regulatory requirements. Strong knowledge of risk based C&Q strategies including ASTM 2500E and ISPE baseline guide rev 2 . Knowledge of latest aseptic requirements including Annex 1 Collaborate with internal stakeholders, including engineering, quality assurance, and operations teams, to ensure validation activities are properly coordinated and executed. Review and follow-up technical documentation from the early design phase in order to ensure alignment with GMP and CQV requirements including investigating and the resolution of technical issues. Schedule preparation and progress review, including the coordination and review daily qualifications tasks associated to the project. 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. Collaborate with vendors and suppliers to ensure the proper installation, qualification, and maintenance of fill finish equipment. Final Handover reports to the Client users Ability to lead and direct CQV teams during document creation and execution. Desired Skills & 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. 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 the ability to analyze complex data sets. 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. 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 would be advantageous Excellent problem-solving skills and the ability to analyze complex data sets. 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. Other Required Skills & Abilities: Detail oriented, self-motivated and a team player Ability to perform critical analysis of situations and provide recommendations Problem solving, creative thinking, and interaction with upper management and design teams Experience in the pharmaceuticalsector is essential Ability to work independently with structured guidance Possess excellent interpersonal, organizational, writing and communication skill Skills: Commissioning C&Q Clean Utilities DeltaV