C&Q Specialist

Mirus Consulting Group; Manatí (PR); On-site; USD 85,000 - 115,000; Full time

Job summary

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.

Responsibilities

• 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.

Education

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

Job description

mîrus Consulting Group is a local company based in Humacao, Puerto Rico that provides computer system validation and information technology consulting services to pharmaceutical companies and other organizations across the Island and parts of the United States. Its services include the assessment and validation of automation equipment, network infrastructures and business processes, as well as the project management involved.

Position Summary

The Commissioning & Qualification (C&Q) Specialist is responsible for supporting commissioning, qualification, and validation activities for manufacturing, utility, facility, and laboratory systems within a regulated pharmaceutical environment. The individual will ensure equipment and systems are installed, tested, documented, and operated in compliance with applicable GMP requirements, corporate procedures, and regulatory expectations.

Key Responsibilities

• 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.

Required 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.
• Experience with manufacturing equipment, facilities, and utility qualification activities.
• Strong technical writing and documentation skills.
• Ability to manage multiple priorities in a fast-paced project environment.
• Proficiency in Microsoft Office applications.

This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.