CSV Engineer/Analyst
4 weeks ago
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
- Documenting impact and risk assessments as part of a team.
- Completing user interface testing, software verification, and complete alarm testing on automated systems.
- Developing, reviewing, and executing testing documentation.
- Making recommendations for design or process modification based on test results when executing test scripts.
- Hands on experience with lab techniques and general lab analytical operations.
- Understanding of baselined lab standards and system suitability verification.
- Basic experience with IT system formats, configurations, and workflows.
- General understanding of the business processes supporting one or more domains, such as: R&D, Clinical, Quality System Management, Supply Chain & Logistics, Commercialization.
- Review and revision of all IT CSV project and system deliverables including but not limited to:
- Plans
- Requirements
- Specifications
- Test Protocols, Scripts and associated execution deliverables (such as test incident reports, etc.
- Summary Reports
- Change Controls
- Review system operational and administration procedures to ensure they are adequate
- Document any findings of non-compliance
- Assist with strategy regarding remediation activities
- Assist with review of remediation activities
- Strong CSV QA/DI knowledge needed
- Experience in pharmaceutical cGxP setting with the ability to generate CSV deliverables with support of mentor.
- Ability to work as part of a team.
- Experience in GMP regulated environment.
- Proven attention to detail and organization in project work.
- Capable of working on assigned tasks without mentorship.
- Demonstrated ability to generate CSV deliverables independently.
- Ability to work independently and as part of a team, with the ability to transition between the two.
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
For more information about our company, please visit us at Verista.com
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.
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