Computer System Validation Engineer - SGP Technology : Job Details

Direct message the job poster from SGP Technology

Head of Automation Life Sciences (DCS, PLC, SCADA and MES) - Delivering the Experts Behind Process Controls & Automation / Industry 4.0 & Digital…

SGP Technology have recently partnered up with a rapidly growing System Integrator in the United States that are rapidly scaling their Validation Engineering team. Due to continued growth, strategic investments, and a strong pipeline of pharma and biotech projects, my client is currently looking to hire for a CSV Engineer on a Permanent basis to support their project delivery across key life sciences accounts.

The Computer System Validation (CSV) Engineer will be responsible for ensuring that all manufacturing and laboratory systems meet applicable regulatory standards and compliance expectations. This includes the development, implementation, and upkeep of validation strategies, protocols, and documentation to support the full lifecycle of GxP-compliant systems.

As a CSV Engineer, you will be involved in:

• Serve as the primary client interface for computer system validation (CSV) activities across control systems and standalone production platforms.
• Prepare and execute validation documentation, including test scripts (IQ, OQ, SFAT, HFAT), traceability matrices, and supporting protocols.
• Ensure all validation deliverables align with GxP, FDA, ISO, and other applicable regulatory standards.
• Work closely with clients to gather requirements and ensure project deliverables meet expectations.
• Support the design, configuration, and implementation of Manufacturing Execution System (MES) solutions.

As a CSV Engineer, you will need to have the following:

• Experience delivering computer system validation (CSV) in FDA-regulated environments such as pharmaceutical, biotech, or medical device industries.
• Strong understanding of GAMP guidelines and 21 CFR Part 11 compliance.
• Proficient in producing SDLC documentation, including Functional Requirements Specifications (FRS), Software Design Specifications (SDS/HDS), and configuration specs.
• Comfortable with the full MES project lifecycle, including design, documentation, testing, and deployment within biopharma environments.
• Strong communication and collaboration skills for effective client and team engagement.

** Please note that our client can Sponsor for Applicants on H1B Visas **

Seniority level

• Seniority levelAssociate

Employment type

• Employment typeFull-time

Job function

• IndustriesPharmaceutical Manufacturing, Biotechnology Research, and Engineering Services

Referrals increase your chances of interviewing at SGP Technology by 2x

Get notified about new System Validation Engineer jobs in Maryland, United States.

Baltimore, MD $75,000.00-$106,000.00 2 weeks ago

Senior Computer Systems Validation EngineerLead Validation Engineer or Specialist, Equipment

Silver Spring, MD $122,000.00-$150,000.00 2 weeks ago

Maryland, United States $150,000.00-$170,000.00 4 weeks ago

Test Engineer - TS Clearance with FS Polygraph

Fort Meade, MD $225,000.00-$225,000.00 1 week ago

Fort Meade, MD $95,000.00-$200,000.00 2 months ago

Test Engineers - multiple levels - CLEARANCE and POLYGRAPH REQUIRED

Hanover, MD $85,000.00-$250,000.00 4 weeks ago

Test Engineers - multiple levels - CLEARANCE and POLYGRAPH REQUIRED

Annapolis Junction, MD $85,000.00-$250,000.00 4 weeks ago

Test Engineers - multiple levels - CLEARANCE and POLYGRAPH REQUIRED

Laurel, MD $85,000.00-$250,000.00 4 weeks ago

We're unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

#J-18808-Ljbffr