Senior Validation Engineer

Novozen Healthcare LLC; New Jersey; On-site; USD 80,000 - 110,000; Full time

Job summary

An innovative firm in the pharmaceutical sector is seeking a CQV Validation Engineer to lead critical validation activities. This role involves executing IQ/OQ/PQ protocols for vital systems, ensuring strict adherence to regulatory standards, and collaborating with cross-functional teams to maintain compliance. The ideal candidate will have a strong background in validation within the biotech industry and be well-versed in cGMP guidelines. Join a dynamic team where your expertise will contribute to the success of groundbreaking projects and regulatory excellence.

Qualifications

• 4+ years of experience in CQV or validation within the pharmaceutical or biotech industry.
• Strong knowledge of FDA, EMA, cGMP, GAMP 5, and ISPE guidelines.

Responsibilities

• Lead and execute CQV activities including IQ/OQ/PQ for equipment and systems.
• Prepare and review validation protocols and ensure compliance with regulations.

Skills

CQV Activities

IQ/OQ/PQ Protocols

cGMP Guidelines

Risk Assessments

Documentation Compliance

Education

Bachelor's degree in Engineering

Bachelor's degree in Life Sciences

Tools

MS Office

TrackWise

VMS

Job description

Job Title: CQV Validation Engineer

Key Responsibilities:

• Lead and execute CQV activities including IQ/OQ/PQ for equipment, utilities, and systems such as autoclaves, clean steam, purified water, HVAC, and process equipment.
• Prepare and review validation protocols, reports, and summary documents following cGMP and regulatory guidelines.
• Support process and cleaning validation activities as needed.
• Collaborate with engineering, QA, manufacturing, and regulatory teams to ensure compliance.
• Conduct risk assessments, impact assessments, and change controls related to validation.
• Ensure data integrity and documentation compliance in line with FDA, EMA, and other international standards.
• Assist with deviation investigations and CAPA related to validation failures.
• Support regulatory inspections and internal audits.
• Track project timelines and validation deliverables to ensure CQV plan success.

Required Qualifications:

• Bachelor's degree in Engineering, Life Sciences, or related field.
• 4+ years of experience in CQV or validation within the pharmaceutical or biotech industry.
• Strong knowledge of FDA, EMA, cGMP, GAMP 5, and ISPE guidelines.
• Hands-on experience with process equipment, utilities, HVAC systems, etc.
• Experience in writing and executing IQ/OQ/PQ protocols.
• Proficiency with documentation systems and validation lifecycle practices.

Preferred Skills:

• Experience with biologics or sterile manufacturing facilities.
• Familiarity with CSV (Computer System Validation) is a plus.
• Proficient in MS Office, VMS, TrackWise, or similar systems.

Seniority level: Mid-Senior level

Employment type: Contract

Job function: Science and Engineering

Industries: Pharmaceutical Manufacturing and Biotechnology Research