6441 - CSV 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.

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

Job Overview: We are seeking a Validation Engineer to own document and data control for the C Q team, including repository structure, ValGenesis entity/document routing, Autodesk Forma turnover documentation, review/approval tracking, executed record quality, and closeout readiness.

Validation Engineer Responsibilities:

Build and maintain document trackers covering system requirements, SLIA/SCA/BCA, DQ, QRA, ERES/data integrity, QP, configuration specifications, traceability matrices, commissioning documents, IOQ/PQ, QSR, green tag, and blue tag

Coordinate document templates, table-of-contents reviews, formal routing, comment incorporation, approval readiness, and final retrieval/closeout packages

Maintain distribution list, team roster, meeting minutes, action items, and document status dashboards for PM use

Track gaps between construction turnover packages, vendor documentation, commissioning evidence, and qualification records

Job Requirements:

Bachelor’s Degree or equivalent required

5-10+ years GMP document control or validation document management

ValGenesis strongly preferred

Autodesk Forma or construction turnover tool experience

GDP and electronic records fluency

Knowledge of GMP documentation standards and electronic quality management systems

Excellent organizational and communication skills

This role requires the ability to be on-site, full-time in Devens, MA.

For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.

*Verista is an equal opportunity employer.

National (US) Range

$70,491 $113,521 USD

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