CSV Lab Engineer / Analyst - 5058 - 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

Responsibilities:

• Expert in CSA validation principles.
• Develop a strategy to convert existing CSV approaches to lab validation into a CSA documented process.
• Developing, reviewing, and executing testing documentation.
• Direct experience and understanding of complex lab systems such as HPLC, GC, TOC, UV/Vis, Plate Readers and automated titrators
• 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: Clinical, Quality System Management, Commercialization.
• Create 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

Requirements

• Must be willing to work onsite in Indianapolis, IN
• Strong understanding of CSA principles and how to leverage them in a lab validation setting.

• Experience in pharmaceutical cGxP setting with the ability to generate CSV deliverables with support of mentor.
• Act as the Subject Matter Expert on various pieces of lab equipment
• Demonstrated experience in leading lab CSV activities specific to Process Equipment
• 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.
• Proficiency using PC and Microsoft Office tools
• Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms
• Ability to work as part of a team
• Strong problem-solving and critical thinking skills
• Excellent organizational and time management skills
• Strong attention to detail
• GMP and Good Documentation Practice
• Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes)
• Basic skills with EXCEL and PowerPoint
• Strong interpersonal skills and clear communication capabilities
• Experience with and tolerance for high levels of challenge and change
• Experience in GMP regulated environment
• Proven attention to detail and organization in project work
• Capable of working on assigned tasks without mentorship

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.

<$65,000 to $95,205>

*Verista is an equal opportunity employer.