CQV Engineer – GMP Validation & Commissioning

IPS - Integrated Project Services, LLC; Lexington (KY); On-site; USD 67,050 - 111,750; Full time

Benefits offered by this job

Certification pay 75%

Referral bonuses $5,000

Membership reimbursement

Overtime pay after 40 hours

Job summary

IPS is seeking a CQV Engineer to support commissioning, qualification and validation activities for life sciences facilities. You will perform cGMP-compliant services, develop and witness FATs/SATs, and prepare C/Q/V documents, reports, and data packages, while adhering to IPS standards and client requirements.

Responsibilities include field execution, walkdowns of drawings, deviation investigations, and collaboration with project teams to ensure successful start-up and validation outcomes

Qualifications

• Bachelor's degree in Engineering required.
• 2+ years of relevant experience in CQV/validation or QA advantageous.
• Experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA preferred.

Responsibilities

• Write C/Q/V documents following established IPS templates and standards.
• Perform field/site activities including witnessing FATs and SATs and execution of C/Q/V protocols.
• Walkdown and verification of system drawings (P&IDs, as-built documentation) and data package preparation.
• Assist in deviation investigations and issue resolution during field execution.
• Collaborate with Project Delivery/CM on start-up and vendor testing; witness and troubleshoot as required.

Skills

cGMP compliance

CQV processes

Education

Bachelor of Science in Engineering

Job description

IPS is seeking a CQV Engineer to support commissioning, qualification and validation activities for life sciences facilities. You will perform cGMP-compliant services, develop and witness FATs/SATs, and prepare C/Q/V documents, reports, and data packages, while adhering to IPS standards and client requirements.

Responsibilities include field execution, walkdowns of drawings, deviation investigations, and collaboration with project teams to ensure successful start-up and validation outcomes