Computer Systems Validation Engineer

AM Technical Solutions- Who Are We:

AM Technical Solutions (AM), founded in 1994, is a proven and licensed architecture, engineering, and construction firm bringing innovative solutions to the Biopharma industry to help in the fight to save lives.  Our knowledge and expertise in high-tech spaces combined with our culture-first mentality allows our team to deliver the entire scope of work for high-tech construction projects on schedule, on budget, and at the level of quality required by customers.  AM Life Science being an integrated part of AM Technical Solutions brings new energy and ideas to an ever-changing industry. Our team is comprised of motivated, intelligent, capable and qualified individuals who design, execute and manage projects and programs that implement risk-based approaches utilizing scientific data and justifications to align with the regulatory and industry standards. AM Life Science takes pride in our accuracy, efficiency, and integrity, which translates into cost and time savings for our Clients.

 

Job Title: 

Computer Systems Validation (CSV) Engineer

Current Locations:

Providence, RI

Position Description

AM is looking for experienced Computer Systems Validation Engineers to be responsible for projects in quality, implementation, and execution as they relate to the biomanufacturing, biotech, and other regulated industries (GAMP5).

This person will be integrated into the early stages of the site buildouts to establish all aspects of the engineering lifecycle and facilities needs including the startup, commissioning, validation, biopharma manufacturing facility.

This individual will be a key member of AM and lead a team responsible for delivering the CSV Program at the site.

 

Direct Involvement Opportunities:

  • The role will be responsible for performing Gap Assessment on existing computerized systems.
  • Possess system quality and compliance knowledge of Computer System GxP regulations (21CFR Part 11, Annex 11 & ISPE GAMP guidelines).
  • Experience with hands-on authoring/review/approval of computer system validation deliverables. These may include: Validation Plan, Risk Assessments, Design Specification, Configuration Specification, Functional Specification, IQ, OQ, & PQ Protocols, Traceability Matrix and Validation Summary Reports.
  • Comfort authoring, dry running, & review & approval of IQ, OQ, and PQ test scripts.
  • Minimum 5 years of CSV Experience in the Pharma Domain.
  • Demonstrates strong organizational, verbal, written, and presentation skills.
  • Additional experience with Equipment, Facility, and Utility Validation is a plus.

Qualifications, Skills, And Experience:

  • Bachelor’s degree or equivalent in Engineering, Science, or related discipline
  • 5+ years of experience working in a GMP manufacturing facilities role.
  • Ability to effectively communicate with all levels within the organization
  • Ability to build collaborative relationships with colleagues and clients
  • Demonstrated effectiveness in a dynamic, fast-paced, and ever-changing environment.
  • Able to deal with pressure, take on challenging projects, manage competing priorities, and anticipate problems in advance