Sign upLog in

Validation Engineer

Inteletech Global

Jersey City, New Jersey

Apply
JOB DETAILS
SKILLS
Analysis Skills, Biotech and Pharmaceutical, Code of Federal Regulations, Communication Skills, Computer Science, Computer Systems, Consulting, Cross-Functional, Customer Support/Service, Data Quality, Demographics, Detail Oriented, Document Change Management, Equipment Maintenance/Repair, Establish Priorities, Hazardous Materials/Substances, High Tech Industry, Identify Issues, Information Technology & Information Systems, Manufacturing, Manufacturing Systems, Marketing, Microsoft Excel, Microsoft Office, Microsoft Outlook, Microsoft Visio, Microsoft Word, Multiplatform/Cross-Platform, Multitasking, Problem Solving Skills, Process Validation, Purchasing/Procurement, Quality Assurance, Regulatory Compliance, Sales, Sales Qualification, System Validation, Systems Administration/Management, Systems Maintenance, Technical Drawing, Technical Writing, Test Plan/Schedule, Validation Documentation, Validation Plan, Vendor/Supplier Management
LOCATION
Jersey City, New Jersey
POSTED
30+ days ago
Benefits:
  • 401(k)
  • 401(k) matching
  • Bonus based on performance
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.

  • Supervise vendors during qualification processes.

  • 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:

  • Proficient in MS Office (Word, Excel, Visio, Outlook).

  • 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.

Work Environment:

  • Office, laboratory, or manufacturing setting.

  • Must be able to work safely around hazardous or infectious materials.

  • No travel required.

Compensation: $40.00 per hour




About the Company

I

Inteletech Global

Resume Resources

Free Resume TemplatesFree Resume Builder