CQV Engineer​/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.

• Managing and working collaboratively with quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities, including root cause analysis.
• Supporting client change management program – including authoring proposed changes, executing impact assessments/regression analysis, and supporting client documentation of change results and release.
• Authoring, editing, and executing technical commissioning, qualification and validation documentation for manufacturing equipment/systems/software, and processes as part of the team directed by the project leader.
• Running test scripts and documenting results.
• Adhering to project schedule for all assigned activities.
• Maintaining clear, detailed records of qualification and validation.
• Documenting impact and risk assessments as part of a team.
• Developing, reviewing, and executing testing documentation.
• General understanding of capital equipment implementation and process knowledge.

• Bachelor’s Degree or equivalent required (STEM degree, Biomedical Engineering, Chemical Engineering preferred).
• 3+ years of industry experience.
• Strong experience authoring and executing protocols in Val Genesis required.
• Experience setting up/implementing Val Genesis instance preferred.
• 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, full‑time in Devens, MA.

National (US) Range: $70,491 - $109,101 USD

• 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.
• Supplemental Life, Hospital, Critical Illness and Legal Insurance.
• Health Savings Account.
• Paid Time Off (Rollover Option) and Holidays.
• As Needed Sick Time.
• Tuition Reimbursement.
• Team Social Activities.
• Employee Recognition.
• Employee Referral Program.
• Paid Parental Leave and Bereavement.

* Verista is an equal opportunity employer.