Job Description

We are looking for an ambitious Computer Systems Validation Engineer (CSV) ready to take on new challenges.

 

YOUR ROLE: Computer Systems Validation

 

  • Coordinate validation activities for an MES rollout
  • Detailed project planning specific to the validation related activities
  • Generation, signoff & execution of various program & GMP related documents and protocols, including a number of the following: validation master plan, URS, FRS/DS, traceability matrix, test specs, IQ, OQ, Integrated OQ & PQ, relevant summary reports and change controls




Qualifications

Basic Qualifications

  • BS or MS in Engineering, Life Sciences or IT is preferred
  • Minimum of 5 years computer systems validation experience in a GMP / FDA regulated environment
  • Familiar with ISA 95
  • Familiar with SDLC based on GAMP 5
  • Exposure to any of the following systems is highly desirable: 
  • MES (Werum, Rockwell PMX or Pharm Suite, Honeywell POMS, XFP etc.)
  • Previous experience working as part of a large, multi-disciplinary team completing full project life-cycle implementations
  • Excellent technical writing skills
  • Strong analytical, problem solving and interpersonal skills required
  • An ability to influence and guide team members when required

 

Requirements


  • Knowledge of FDA and GMP guidelines a must
  • Working knowledge of software Development Life Cycle (SDLC) and support methodologies required
  • Understanding of Life Sciences validation processes required

 

Set Yourself Apart   


  • Bachelors’ degree in Science, Engineering or relatable technical degree
  • Strong written and oral communication skills needed
  • Ability to work in a team-oriented, collaborative environment
  • Ability to facilitate meetings and follow up with resulting action items

 

All our consulting professionals receive comprehensive training covering business acumen, technical and professional skills development. You'll also have opportunities to hone your functional skills and expertise in an area of specialization. We offer a variety of formal and informal training programs at every level to help you acquire and build specialized skills faster. Learning takes place both on the job and through formal training conducted online, in the classroom, or in collaboration with teammates. The sheer variety of work we do, and the experience it offers, provide an unbeatable platform from which to build a career. 


All employment decisions shall be made without regard to age, race, creed, colour, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as applicable by law.

Job candidates will not be obligated to disclose sealed or expunged records of conviction or arrest as part of the hiring process.

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