CSV Engineer / Validation Engineer
- Indianapolis, IN
- $56,980-85,000 per year
- Permanent
- Full-time
- 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
- Developing, reviewing, and executing laboratory CSV documentation
- Hands on experience with lab techniques and general lab analytical operations
- Complete protocol and qualification activities
- Understanding of baselined lab standards and system suitability verification
- Basic experience with IT system formats, configurations, and workflows
- Document any findings of non-compliance
- Assist with strategy regarding remediation activities
- Assist with review of remediation activities
- Direct experience and understanding of complex lab systems such as HPLC, GC, TOC, UV/Vis, Plate Readers and automated titrators
- Knowlege of CSA/CSV principles and how to leverage them in a lab validation setting
- Must be willing to work onsite in Indianapolis, IN
- Experience in pharmaceutical cGxP setting
- Demonstrated experience in generating and completing laboratory CSV deliverables
- Experience with TrackWise, Veeva, DeltaV and/or Empower preferred
- Experience in GMP regulated environment
- Proven attention to detail and organization in project work
- Capable of working on assigned tasks without mentorship
- Ability to work independently and as part of a team
- Proficiency using PC and Microsoft Office tools
- Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms
- Strong problem-solving and critical thinking skills
- Excellent organizational and time management skills
- Strong attention to detail
- GMP and Good Documentation Practice
- Experience with and tolerance for high levels of challenge and change
- 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