CSV Engineer

Job Title: CSV Engineer Location: Pittsburgh, PA (100% On-site)

Experience : 3 - 5 Contract Duration: 6 Months (Extension Expected | 18+ Months of Work)

Client Overview:

Fast-growing, well-funded Cell and Gene Therapy company.

Working on the cutting edge of gene editing, iPSC technologies, and protein engineering.

Developing a state-of-the-art 125,000 sq ft greenfield manufacturing facility near Pittsburgh, PA (started in 2024; targeted operational date: Q1 2027).

In partnership with University of Pittsburgh .

Project Scope:

The facility is currently under construction; electrical systems go live in January 2026.

Client is implementing multiple computer systems to support the facility.

Actively implementing Blue Mountain RAM ; Validation Master Plan in development.

Looking to onboard a CSV Engineer (Owner’s Representative) to support system implementation and validation activities.

Work Schedule:

5 days/week On-site

Standard Business Hours: 8:00 AM – 4:00 PM or 9:00 AM – 5:00 PM

Technology Environment:

Blue Mountain RAM

Microsoft Suite

Kneat

Veeva

Day-to-Day Responsibilities:

Support the implementation of multiple Computer Systems .

Assist in developing the Validation Master Plan (VMP) .

Author, review, and manage SOPs , ensuring all vendor documentation complies with 21 CFR Part 11 and GAMP standards.

Write addendums to SOPs when necessary.

Support and execute validation protocols, scripts, and reports .

Collaborate with project team members to ensure validation documents are accurate and compliant.

Ensure that all system modifications remain Part 11 and GAMP compliant.

Required Skills:

Proven experience as an Owner’s Rep CSV Engineer on Greenfield projects .

Background in Cell and Gene Therapy environments.

Strong knowledge of Blue Mountain RAM , Automation Systems , and Building Management Systems (BMS) .

Hands-on experience with:

Validation documentation (protocols, scripts, reports)

Validation execution

SOP writing and revisions

Ensuring regulatory compliance (21 CFR Part 11, GAMP)

Supporting the creation of VMPs

Desired Skills:

Familiarity with Kneat (Validation Lifecycle Management)

Experience with Veeva (Document Management)