Senior CSV Engineer (Polarion) / Senior Validation Engineer 2 - 5067 - Verista

Verista’s 600 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

Senior CSV Engineer Responsibilities:

Our team needs a senior level CSV Engineer with ALM experience, ideally with Polarion. Experience with ALM tools such as Kneat, Valgenesis may be considered in lieu of Polarion experience. This person should have strong lab informatics (LIMS, data archive, ELN, etc.), good/deep LabVantage experience, and be well versed in CSA methodology and be able to handle projects (from a technical and validation perspective) such as:

1. Calculation validations in LabVantage

2. Instrument integration with LabVantage

3. JMP/Statistica integration with LabVantage

4. Data migration from legacy stability system into LV and legacy system decommissioning

5. Integration of Sarepta LIMS with CMO LIMS

6. Splashlake

Requirements

• A minimum of a Bachelor’s degree in an Engineering or Scientific degree and 6-10 years of role relevant experience

• Demonstrated experience working with Polarion highly preferred, MUST have significant experience using ALM software

• Strong Lab Informatics experience

• Direct experience with LIMS (LabVantage)

• Obvious business maturity and interpersonal skills to be able to effectively communicate and collaborate

• Experience and capability of effectively communicating requirements (written and orally) with rationale to different levels of the client’s organization

• Proven attention to detail and organization in project work

• Capable of working on assigned tasks without mentorship

• Experience authoring/editing/executing validation documents for laboratory equipment

• Working knowledge of FDA regulations, ISPE guidelines and ISO standards including:

• Good Documentation Practice (GDP) in pharmaceutical environment

• 21 CFR Part 11

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

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.

$80,465-121,170

*Verista is an equal opportunity employer.