Validation Engineer

Inteletech Global Inc; Jersey City (NJ); On-site; USD 55,104; Full time

Job summary

A leading global consulting firm is seeking a Validation Engineer in Summit, New Jersey. This contract role requires 4-7 years of experience in the pharmaceutical or biotech sectors with a strong background in Computer System Validation (CSV). Responsibilities include maintaining validated systems, drafting validation documents, and supporting cross-functional teams. Ideal candidates must have a Bachelor's degree in Engineering or Computer Science, and excellent technical writing skills are a must. Competitive compensation at $40.00 per hour is offered.

Qualifications

• 4-7 years of experience in the pharmaceutical or biotech industry.
• Strong understanding of 21 CFR Part 11 and data integrity.
• Experience in interpreting engineering documentation and technical drawings.

Responsibilities

• Maintain qualified/validated equipment and systems.
• Draft and execute validation documents like Validation Plans and Summary Reports.
• Support change management and document lifecycle activities.

Skills

Computer System Validation (CSV)

Technical writing

Presentation and communication skills

Attention to detail

Education

Bachelor’s degree in Engineering or Computer Science

Job description

Job Title: Validation Engineer (Contractor)

Location: Summit – West, New Jersey

Type: Contract

Job Description:

We are seeking a Validation Engineer with 4–7 years of relevant experience to support validation activities in a pharmaceutical/biotech environment. This role will involve qualifying and maintaining equipment and systems in compliance with regulatory and company standards. Candidates with more than 10 years of experience will not be considered.

Key Responsibilities:

• Maintain qualified/validated equipment and systems following company procedures and policies.
• Draft and execute validation documents: Validation Plans, IQ/OQ/PQ, URS, RTM, Test Plans, Deviations, and Summary Reports.
• Support change management and document lifecycle activities.
• Configure and document computerized system configurations.
• Perform and lead equipment qualification and CSV efforts for lab/manufacturing systems.
• Coordinate equipment implementation from procurement to qualification.
• Support cross-functional teams including QA, Facilities, and Lab personnel.
• Prioritize and respond to qualification support requests promptly.
• Provide excellent customer service and foster a team environment.

Must-Have Qualifications:

• Bachelor’s degree in Engineering, Computer Science, or equivalent (or Associate’s degree with 4+ years of experience).
• 4–7 years of experience in pharmaceutical or biotech industry.
• Expertise in Computer System Validation (CSV).
• Strong understanding of 21 CFR Part 11, data integrity, and folder permission management.
• Skilled in technical writing and generating validation deliverables.
• Experience working in fast-paced environments with strong multi-tasking skills.

Technical Skills:

• Ability to interpret engineering documentation and technical drawings.
• Strong presentation and communication skills.

Preferred Attributes:

• Action-oriented with a focus on quality and attention to detail.
• Strong problem-solving and troubleshooting skills.
• Ability to build effective working relationships and function in a team setting.
• Office, laboratory, or manufacturing setting experience.
• Must be able to work safely around hazardous or infectious materials.

Compensation: $40.00 per hour