Commissioning and Qualification Lead

About the Role:
We are seeking an experienced Commissioning and Qualification (C&Q) Lead to oversee and drive the execution of C&Q activities for our cutting-edge projects in the pharmaceutical sectors. The ideal candidate will lead cross-functional teams, ensuring compliance with regulatory requirements while delivering projects on time and within budget.

Key Responsibilities:

• Lead and manage the full lifecycle of Commissioning and Qualification activities, including planning, execution, and closeout.
• Develop and implement C&Q strategies aligned with client objectives, regulatory requirements (FDA, EMA, etc.), and industry standards (ISPE, GAMP).
• Oversee generation and review of critical C&Q documentation (URS, DQ, FAT, SAT, IQ, OQ, PQ protocols).
• Collaborate with engineering, quality, and operations teams to ensure seamless integration of equipment and systems.
• Identify project risks, establish mitigation plans, and ensure timely issue resolution.
• Provide mentorship and leadership to junior engineers and consultants.
• Ensure validation deliverables meet Good Manufacturing Practices (GMP) and Good Engineering Practices (GEP).
• Support audits and regulatory inspections as a subject matter expert.

Qualifications:

• Bachelor's degree in Engineering, Life Sciences, or related field (Master's degree preferred).
• Minimum 7-10 years of hands-on experience in Commissioning, Qualification, and Validation (CQV) in the pharmaceutical or biotech industry.
• Strong knowledge of regulatory guidelines (FDA, EMA, ICH, ISPE, ASTM E2500).
• Proven track record leading large-scale projects from concept to completion.
• Excellent leadership, communication, and problem-solving skills.
• Ability to manage multiple priorities in a fast-paced environment.
• PMP Certification, Lean Six Sigma, or equivalent is a plus.

Why Join Us?

• Be part of high-impact projects in a rapidly evolving industry.
• Work alongside a dynamic and skilled team of professionals.
  
  Note: As part of the job you are required to commute to the site. We do not offer relocation package.

"Drug Free Workplace Policy: In accordance with our commitment to maintaining a safe and productive work environment, all applicants for employment with our company are required to affirm their commitment to a drug-free workplace and consent to pre-employment drug testing as a condition of employment."

Share Tech Group is committed to being an equal opportunity employer, fostering a diverse and inclusive workplace where all individuals are treated with respect and provided with equal opportunities for employment and advancement.