Commissioning Engineer – Senior

Title: Commissioning & Qualification (C&Q) Engineer
Department: Technical Compliance
Reports to: Principal Engineer

Overview:
This role supports commissioning and qualification (C&Q) activities for systems and equipment at a pharmaceutical manufacturing site. Key responsibilities include protocol preparation and execution for equipment such as reactors, centrifuges, dryers, utility systems, and cleanroom environments, ensuring compliance with cGMP standards.

Responsibilities:

• Support C&Q activities from design through execution.
• Develop and execute protocols (e.g., URS, DQ, IQ, OQ, PQ) and review vendor documents (e.g., FAT, SAT).
• Coordinate C&Q activities with engineering, contractors, and site operations.
• Address commissioning punch lists and qualification deviations.
• Ensure documentation meets site change control requirements.
• Collaborate with Quality teams to maintain compliance.

Experience and Skills:

• Minimum 5+ years in the pharmaceutical industry, with experience in commissioning and qualifying systems such as reactors, dryers, and clean utilities.
• Strong knowledge of cGMP, GEP, and risk-based qualification approaches.
• Proficiency with Microsoft Office and familiarity with ABB Industrial IT systems is advantageous.

Qualifications:

• Degree in a relevant field.
• Excellent communication, problem-solving, and teamwork skills.
• Strong attention to detail and adaptability in a dynamic environment.

EHS Considerations:

• Adhere to all environmental, health, and safety policies and procedures.
• Use PPE as required and report safety incidents promptly.

This role offers an opportunity to work in a collaborative, compliance-focused environment supporting pharmaceutical manufacturing projects.