6441 - CSV Engineer / Validation Engineer
Verista, Inc.
Harvard, United States of America
7 days ago
Role details
Contract type
Permanent contract Employment type
Full-time (> 32 hours) Working hours
Regular working hours Languages
English Experience level
Senior Compensation
$ 114KJob location
Harvard, United States of America
Tech stack
Software Documentation
Data Integrity
Document Management Systems
Software Requirements Analysis
Autodesk Autocad
Job description
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, * 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
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.
Benefits & conditions
Pulled from the full job description
- Referral program
- Tuition reimbursement
- Paid parental leave
- Parental leave
- Health insurance
- 401(k) matching
- Paid time off, 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
About the company
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.