Computer System Validation Specialist Engineer Job at GForce Life Sciences, Pittsburgh, PA

Y0pFTFg3aWVmTDBjdzg2SzZCd0N2dTFiOEE9PQ==
  • GForce Life Sciences
  • Pittsburgh, PA

Job Description

GForce is seeking a Computer System Validation Specialist Engineer to join a growing leader in the pharmaceutical/biotechnology space for an onsite position in Pittsburgh, PA. The CSV Engineer will lead the implementation and validation of computerized maintenance systems-particularly CMMS platforms like Blue Mountain-ensuring compliance with regulatory and data integrity standards.

Responsibilities of the CSV Engineer include:

  • Author, review, and execute validation deliverables including Validation Plans, URS, Risk Assessments, IQ/OQ/PQ protocols, and Summary Reports.
  • Support the validation of GxP computerized systems such as CMMS, BAS, EMS, and SCMS, ensuring compliance with regulatory and data integrity standards.
  • Apply GAMP 5 and risk-based validation principles to ensure systems meet 21 CFR Part 11, Annex 11, and ALCOA+ requirements.
  • Collaborate with cross-functional teams including QA, IT, Engineering, and Facilities to drive validation readiness and execution.
  • Manage validation lifecycle activities using Kneat or similar platforms, ensuring traceability, audit readiness, and support for change control and deviation processes.

Qualifications for the CSV Engineer include:

  • 5-8 years of experience in Computer System Validation (CSV) or Computer Software Assurance (CSA) within pharmaceutical, biotech, or other regulated life sciences industries.
  • Proven expertise in qualifying GMP computerized systems such as CMMS, BAS, EMS, and SCMS, with a strong grasp of data integrity and compliance requirements.
  • Thorough understanding of GAMP 5, risk-based validation methodologies, and regulatory frameworks including 21 CFR Part 11 and Annex 11.
  • Skilled in authoring and executing validation protocols, test scripts, and technical documentation, with strong organizational and cross-functional collaboration abilities.
  • Bachelor's degree in Computer Science, Engineering, Life Sciences, or a related technical discipline.

Term & Start:

  • Benefits included (Medical, Dental, Vision, 401k)
  • 6 Month Contract with the opportunity to extend
  • 40 Hours Per Week
  • 100% Onsite in Pittsburgh, PA
  • Start Date: As Soon As Possible
  • No Travel

Job Tags

Contract work, Immediate start,

Similar Jobs

ManpowerGroup

Change Management Consultant Job at ManpowerGroup

 ...organization in the insurance industry_ , is seeking a **Change Management Consultant** to join their team, working Hybrid in Chicago, IL or...  ...the latest information regarding a tool's features and best practices.+ Utilize communication channels to gather feedback and... 

BLISS Car Wash

Ticket Writer / Sales Associate Job at BLISS Car Wash

 ...BLISS Car Wash ~ Ticket Writer/ Sales - $500 to $1,000 Sign on Bonus. ~$17.00 - $20.00 hourly base pay, plus commission and incentives. Benefits: ~$500 to $1,000 Sign on Bonus. ~ Hourly plus commission and incentives. ~ Medical, Dental, Vision, Critical... 

Apex Informatics

COBOL Mainframe Developer Job at Apex Informatics

 ...Metro Atlanta****Onsite REQUIRED** Experience: 5 Years Job Description: GDOL is looking for a skilled and experienced COBOL Mainframe Programmer/Developer. This role involves translating business requirements into robust programming solutions, maintaining... 

Covina Pet Care

Part-Time Veterinary Receptionist Job at Covina Pet Care

 ...flow, check in and check out clients and process payments. Our receptionists offer friendly emotional support in a compassionate and...  ...next career move, youll have opportunities through a variety of virtual and hands on, interactive training and continuing development.... 

Verano

Certified Pharmacy Technician - FT Job at Verano

 ...through cannabis and educate them on how it can be used as a wellness product. Build rapport with regular patients/customers to promote...  ...abilities required by this job include hearing in the normal audio range with or without correction. Specific vision abilities required...