5808 - Senior Lab CSV Engineer / Senior Validation Engineer

Description

Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values:

• We empower and support our colleagues


• We commit to client success at every turn


• We have the courage to do the right thing


• We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.


• We constantly acquire new skills and learn from our experiences to enhance our collective expertise

Senior Lab CSV Engineer / Senior Validation Engineer Responsibilities:

We are looking for a skilled lab equipment validation/CSV resource. The qualified candidate must have worked with and validated simple and complex lab instruments, performed execution of instruments with no guidance and interfaced with instrument vendors to determine scope of testing.

• Knowledge and demonstrated experience of Computerized System and Lab Equipment Validation


• Understanding with demonstrated experience drafting and executing validation documents, such as Val Plans, URS, IQ/OQ/PQ protocols, RTM, VSR, Deviation Management, Change Management and Project Management


• Conducting and documenting impact and risk assessments with a full understanding of equipment/system/ software operation and ability to assess direct, indirect, and no impact systems and functions within complex processes


• Experience with requirements gathering and root cause analysis activities


• Adherence with project schedule for all assigned activities


• Maintaining clear, detailed and compliant qualification and validation records


• Understanding of system design and/or configuration activities


• Understanding of system integrations, including but not limited to understanding of how integrations are designed/constructed, data flow from source systems to target systems, typical testing approach for system integrations

Requirements

• Bachelor’s Degree or equivalent required


• 4 to 6 year of relevant role specific experience


• Proficiency using PC and Microsoft Office tools


• Ability to work as part of a team and independently


• Strong problem-solving and critical thinking skills


• Excellent organizational and time management skills


• Strong attention to detail


• Obvious business maturity and interpersonal skills to be able to effectively communicate and collaborate


• Experience and capability of effectively communicating requirements (written and orally) with rationale to different levels of the client’s organization


• Experience in pharmaceutical cGxP setting with the ability to generate CSV deliverables


• Knowledge of 21 CFR Part 11 regulation


• Direct experience and understanding of complex lab equipment/systems

This is an on-site role in Muskegon, MI.

Benefits

Why Choose Verista?

• High growth potential and fast-paced organization with a people-focused culture


• Competitive pay plus performance-based incentive programs


• Company-paid Life, Short-Term, and Long-Term Disability Insurance.


• Medical, Dental & Vision insurances


• FSA, DCARE, Commuter Benefits


• Supplemental Life, Hospital, Critical Illness and Legal Insurance


• Health Savings Account


• 401(k) Retirement Plan (Employer Matching benefit)


• Paid Time Off (Rollover Option) and Holidays


• As Needed Sick Time


• Tuition Reimbursement


• Team Social Activities (We have fun!)


• Employee Recognition


• Employee Referral Program


• Paid Parental Leave and Bereavement

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For more information about our company, please visit us at Verista.com