The Commissioning and Qualification (C&Q) Engineer is responsible for the planning, execution, and documentation of commissioning and qualification activities for facilities, utilities, equipment, and systems in compliance with current GMP regulations and global regulatory expectations. The role ensures that all systems are installed, operated, and performing as intended to support validated manufacturing processes and product quality.

• Lead and support the development and execution of C&Q lifecycle deliverables, including URS, DQ, FAT, SAT, IQ, OQ, and PQ, in alignment with ASTM E2500 and ISPE guidelines.

• Plan and coordinate commissioning and qualification activities for new installations, upgrades, or retrofits of GMP-critical systems (HVAC, clean utilities, process equipment, etc.).

• Collaborate with Engineering, Quality, Manufacturing, and external vendors to ensure compliance, readiness, and proper documentation throughout project phases.

• Prepare and review validation protocols, reports, and risk assessments to ensure technical accuracy and regulatory compliance.

• Identify and resolve deviations, discrepancies, and non-conformances during C&Q execution; ensure timely closure and proper documentation.

• Support change control processes and impact assessments for system modifications.

• Ensure systems meet design requirements, user needs, and are fully GMP-compliant before release to manufacturing.

• Contribute to continuous improvement initiatives in validation practices and C&Q strategy implementation.
  

  Qualifications:

  Education & Experience:

• Bachelor’s Degree in Engineering, Life Sciences, or related field.

• 3+ years of experience in C&Q or Validation Engineering in a GMP-regulated environment (pharmaceutical, biotechnology, medical device).

• Hands-on experience commissioning GMP utilities (e.g., WFI, HVAC, compressed air), process equipment, and automation systems.

Certifications Preferred:

• CQV, PMP, or equivalent certification.

• Training in ISPE Baseline Guides, GAMP5, or ASTM E2500 methodology.

Skills:

• Strong understanding of GMP, FDA, EMA, and ICH regulations related to validation and qualification.

• Proficient in technical writing, document control, and regulatory compliance.

• Familiarity with commissioning software tools, CMMS, and document management systems.

• Strong project management, analytical, and interpersonal skills.

"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.