6248 - Senior 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

Sr. Validation Engineer Responsibilities:

• Provide Computer System Validation (CSV) support for site automation systems, including DeltaV DCS, Syncade MES, and the integration of stand-alone single-use systems with DeltaV and Syncade within a regulated GMP environment
• Lead and execute end-to-end CSV activities for automation changes, including development and approval of validation plans, risk assessments, traceability matrices, IQ/OQ protocols, and summary reports
• Support and drive User Acceptance Testing (UAT) to qualify DeltaV automation updates, ensuring all recipe, sequencing, and flow path changes meet functional and regulatory requirements
• Validate and document updates to batch recipes, sequencing logic, control modules, and process flow paths within the Emerson DeltaV platform
• Partner cross-functionally with Automation, Process Engineering, Manufacturing, and QA teams to ensure timely execution of validation activities and resolution of deviations or test discrepancies
• Ensure compliance with GxP, 21 CFR Part 11, and risk-based validation methodologies while supporting change control and release of qualified automation updates to production

Requirements:

• Bachelor’s Degree or equivalent required (STEM degree, Biomedical Engineering, Chemical Engineering preferred)
• 5 years of industry experience
• Strong experience with Delta V and Syncade MES
• Strong understanding of GxP requirements and 21 CFR Part 11 compliance
• Familiarity with validation lifecycle documentation and electronic protocol management systems
• Strong problem-solving and critical thinking skills
• Excellent organizational and time management skills
• This role requires the ability to be on-site in the Boston, MA area with some potential for local-hybrid work

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