CQV Engineer

Intellectt INC; Massachusetts; On-site; USD 41,000 - 55,000; Part time

Job summary

Intellectt INC is seeking a CQV Engineer to support commissioning, qualification, and validation activities for pharmaceutical manufacturing systems in Massachusetts. This contract role is onsite for 6 months+ and requires close collaboration with Engineering, Quality, Manufacturing, and Validation teams to ensure systems are properly commissioned, qualified, and compliant with GMP requirements.

Responsibilities include executing CQV activities for equipment and utilities, developing and

Qualifications

• 3+ years of CQV/ C&Q experience in pharma manufacturing.
• Hands-on IQ/OQ/PQ and qualification knowledge.
• Experience with P&IDs, drawings, and equipment specs.
• Strong GMP and validation practices.
• Excellent cross-functional communication.

Responsibilities

• Execute commissioning and qualification activities for pharmaceutical manufacturing equipment, utilities, and systems.
• Develop, review, and execute C&Q protocols (IQ/OQ/PQ).
• Perform field verifications, walkdowns, and inspections against P&IDs.
• Support validation plans, test scripts, protocols, reports, turnover.
• Manage punch lists, deviations, and turnover documentation.
• Collaborate with Engineering, Quality, Manufacturing, Automation, and vendors.
• Ensure CQV activities comply with cGMP and regulatory requirements.

Skills

CQV experience

GMP knowledge

Cross-functional collaboration

Documentation proficiency

Education

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

Job description

Job Title: CQV Engineer

Location: Massachusetts
Industry: Pharmaceutical
Employment Type: Contract
Duration: 6 Months +
Work Location: Onsite

About the Role

We are seeking a CQV Engineer to support commissioning, qualification, and validation activities for pharmaceutical manufacturing systems and equipment. The role will work closely with Engineering, Quality, Manufacturing, and Validation teams to ensure systems are properly commissioned, qualified, documented, and compliant with GMP requirements.

Responsibilities

• Execute commissioning and qualification activities for pharmaceutical manufacturing equipment, utilities, and systems.


• Develop, review, and execute C&Q protocols, including IQ, OQ, and PQ documentation.


• Perform field verification, system walkdowns, and equipment inspections against P&IDs, drawings, specifications, and approved documentation.


• Support development and review of validation plans, test scripts, protocols, reports, and turnover packages.


• Identify and resolve commissioning, qualification, and startup issues.


• Manage punch lists, discrepancies, deviations, and qualification documentation through closure.


• Collaborate with Engineering, Quality, Manufacturing, Automation, and external vendors.


• Ensure CQV activities comply with cGMP, company procedures, and applicable regulatory requirements.

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related technical discipline.


• 3+ years of experience in CQV, C&Q, commissioning, or validation within pharmaceutical or biopharmaceutical manufacturing.


• Hands-on experience with IQ/OQ/PQ and equipment/system qualification.


• Experience with field verification, system walkdowns, P&IDs, engineering drawings, and equipment specifications.


• Strong understanding of GMP requirements and pharmaceutical validation practices.


• Experience with qualification documentation, deviations, punch lists, and turnover packages.


• Strong communication and cross-functional collaboration skills.

Salary

The hourly rate for this position is $30-$40 per hour.

Benefits

This is a contract position and does not include employer-provided benefits.

Equal Opportunity Employer

We are an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Background Check

Background checks may be conducted in accordance with applicable law.