Pharma C&Q Specialist: GMP Validation & Commissioning

Mirus Consulting Group; Manatí (PR); Sur place; USD 85 000 - 115 000; Plein temps

Résumé du poste

mîrus Consulting Group, a Humacao-based firm providing pharmaceutical validation and IT consulting, seeks a C&Q Specialist to support commissioning, qualification and validation activities within a regulated environment.

You will ensure equipment, utilities and facilities are installed, tested, documented and operated in compliance with GMP, FDA and cGMP expectations, collaborating with QA and project teams to deliver final packages.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Biotechnology, Chemistry, or a related technical discipline.
• Minimum of 4 years of experience in Commissioning, Qualification, Validation, Engineering, or a related function within the pharmaceutical, biotechnology, or medical device industry.
• Experience executing IQ/OQ/PQ protocols.
• Knowledge of GMP, FDA, EU Annex 15, ISPE, and cGMP regulations.

Responsabilités

• Execute commissioning and qualification activities for equipment, utilities, facilities, and manufacturing systems.
• Develop, review, and execute IQ, OQ, PQ, and commissioning protocols.
• Support system impact assessments, qualification strategies, and risk assessments.
• Coordinate field execution activities, including protocol testing and discrepancy resolution.
• Review engineering documentation including P&IDs, equipment specifications, design documents, turnover packages, and test records.
• Ensure qualification documentation complies with GMP standards and internal procedures.
• Generate and review qualification summary reports and final project documentation.
• Support startup, commissioning, and qualification of process equipment, clean utilities, facilities, and automation systems.
• Investigate deviations, non-conformances, and protocol exceptions associated with validation activities.
• Work closely with Quality Assurance to support protocol approvals and final package acceptance.
• Participate in project meetings and provide updates on qualification status, risks, and deliverables.
• Support regulatory inspections and internal audits as required.
• Maintain compliance with site safety policies and industry regulations.

Formation

Bachelor's degree in Engineering, Life Sciences, Biotechnology, Chemistry, or a related technical discipline

Description du poste

mîrus Consulting Group, a Humacao-based firm providing pharmaceutical validation and IT consulting, seeks a C&Q Specialist to support commissioning, qualification and validation activities within a regulated environment.

You will ensure equipment, utilities and facilities are installed, tested, documented and operated in compliance with GMP, FDA and cGMP expectations, collaborating with QA and project teams to deliver final packages.