5833 - CSV Engineer / Validation Engineer
New Yesterday
Description
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.
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
Responsibilities:
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
Requirements:
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
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.
National (US) Range $56,980—$85,000 USD 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
Verista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details.
For more information about our company, please visit us at Verista.com
- Location:
- Indianapolis
- Category:
- Manufacturing