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Verista · 1 week ago

6042 - CQV Engineer / Validation Engineer 2

Devens, MA

Full-time

Onsite

Mid Level

$70K/yr - $109K/yr

3+ years exp

Verista’s team of 500 experts collaborates with leading brands in the life science industry to address critical business needs. The Validation Engineer will manage quality investigations, support change management programs, and author technical documentation to ensure compliance and efficiency in manufacturing processes.

ComplianceHealth CareLife ScienceManufacturingPharmaceutical

H1B Sponsor Likely

Responsibilities

Managing and working collaboratively with quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities. Includes ability to complete root cause analysis

Supporting clients 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 team as directed by the project leader

Running test scripts and documenting results

Adhering to project schedule for all assigned activities

Maintaining clear, detailed records 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

Understanding validation documents, URS, IQ, OQ, PQ

Qualification

ValGenesisGxP requirements21 CFR Part 11 complianceSTEM degreeProblem-solving skillsCritical thinking skillsOrganizational skillsTime management skills

Required

Bachelor's Degree or equivalent required

3+ years of industry experience

Strong experience authoring, and executing protocols in ValGenesis required

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

Preferred

Biomedical Engineering

Chemical Engineering

Experience setting up/implementing ValGenesis instance

Benefits

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

Company

Verista

Verista offers transformative compliance, automation, packaging solutions for the life sciences, pharmaceutical and manufacturing.

Founded in 1983

Fishers, Indiana, USA

501-1000 employees

https://www.verista.com/

H1B Sponsorship

Verista has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (7)

2024 (4)

2023 (13)

2022 (6)

2021 (1)