CSV Engineer/Analyst - Sn Validation Engineer - 4489
Verista, United States
Job Description
Verista’s600 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 amp; 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
CSV Engineer/Analyst Responsibilities:
- Author Qualification (IQ/OQ) Final Reports for Application upgrade projects.
- Author and review validation protocols including IQ, OQ, and PQ protocols related to Computer Systems for Manufacturing equipment such as bioreactors, TFFs, tube welders, AKTAs, glove integrity testers, filter integrity testers, controlled temperature units etc.
- Author and Review of Validation Deliverables Validation Master Plan (VMP), System Impact Assessment, Risk Assessment, User Requirement Specification Document, Design Specification Document, Configuration Specification document, Data Integrity Assessment, Application Qualification Protocol (IQ/OQ/PQ), Validation Summary Reports.
- Ensure site systems are compliant with the corporate Data Integrity program.
Requirements
- Available to work onsite in Baltimore MD
- Experience in GMP regulated environment
- Proven attention to detail and organization in project work
- Capable of working on assigned tasks without mentorship
- 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
- Ability to communicate effectively with clients
- Proven ability to identify areas of business expansion and report to management team for follow-up
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 amp; 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 atVerista.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.
$70,491-118,941
*Verista is an equal opportunity employer.