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

WXlIa3l5Q3NJUG5HTnFMdm9JOTZFUmdqd0E9PQ==
  • 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

CommonSpirit Health

Radiology Assistant Job at CommonSpirit Health

**Responsibilities**Assists with the workflow within Imaging Services to support efficiency and excellent patient care.+ Checks department wheelchairs and oxygen tanks assuring they are mechanically sound; immediately reports equipment defects to supervisor.+ Ensures... 

BOEING

Power Plant Operators A-P110A Job at BOEING

 ...opportunity for professional growth. Find your future with us. Boeing Commercial Airplanes is excited to offer opportunities for a Power Plant Operators A, to join our team in Renton and Seattle, Washington. As a Power Plant Operator A, you will be a vital part of... 

ABM Industries

Painter Job at ABM Industries

**Overview****Job Summary Details:**The Painter performs necessary carpentry and painting duties to maintain facilities in good repair and appearance.**Pay: $43.88 her hour**The pay listed is the hourly range or the hourly rate for this position. A specific offer will... 

Venatic, Inc

AT&T Sales Account Associate Job at Venatic, Inc

 ...Have you been wanting to start a career in business but unsure of where to begin? At our company, in our AT&T Sales Account Associate position, we will provide you with complete training and mentorship in marketing, communications and customer service while mastering... 

Dayspring Fellowship

Pastor of Children's Ministries Job at Dayspring Fellowship

 ...birth through 5th grade. The PCM should be someone who is passionate about ministry to children and motivated to invest in their spiritual growth. The PCM works closely with the Executive Team to set the direction, priorities and vision of Children's Ministries and is...