C&Q/CQV Engineer

Recruiting Commissioning & Qualification (C&Q) Engineer to join an important project with a Global Biopharmaceutical Company.

Main responsibilities:

• Qualification/Validation phases are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities
• Qualification/Validation Master plans are up to date and established for all ongoing projects• Write/review Qualification/Validation plans, including but not limited to DQ, IQ, OQ, PQ plans/protocols and final reports for new or modified GMP utilities, facilities, and process equipment
• Execution of DQ, IQ, OQ, PQ, including protocol deviations, investigation, and corrective action activities for new or modified GMP utilities, facilities, and process equipment
• Plan and track execution of Commissioning & Qualification activities/documentation versus project(s) timeline
• Prepare, review and approve technical and GMP related documentation (URS, FMEA, impact/risk assessment, Master plans, qualification/validation documentation)
• Coordinate and execute FAT/SAT, commissioning activities for new GMP systems in collaboration with internal and external partners
• Coordination and oversight of external suppliers

Candidate’s Requirements:

• Bachelor/Master’s degree in Chemical/Mechanical Engineering
• Certification in NDT/ ASME would be added advantage
• A minimum of 5 years of working experience within pharma company in C&Q/CQV equivalent position
• Know-how of Qualification requirements according to cGMP regulations
• Experience working with cross-department stakeholders
• Know-how of quality assurance principles
• Experience working in project teams and multiple projects in parallel
• Experience working with ISPE baseline guides is a plus
• Analytical thinking and problem-solving ability
• Ability to interact with other departments / disciplines;
• Experienced in the supervision of personnel and team working;
• Budget and cost control experience;
• Flexible and able to comply/adapt to company and client requirements;
• Confident and able to work on own initiative;
• Offshore / Onshore experience in similar role;
• Demonstrates a commitment to safety;
• Must be Able to Work at site / offshore as and when required;
• Knowledge and use of planning systems;
• Delivery focused and committed to achievement of project goals;
• Self time management