CQV Engineer - 3994MC

Who are we:

Verista’s 700 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. Whether it’s compliance, quality management, verification, validation, automation, IT infrastructure, data analysis, manufacturing, or packaging, we deliver solutions that are right the first time.

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

This role will require 100% onsite work in Bloomington, IN

Typical Project Accountabilities Include:

• Provide technical CQV (commissioning, qualification, and verification) expertise on projects involving new or modified laboratory equipment and computer systems, ensuring CQV aspects are delivered consistently and efficiently. Includes authoring and executing documents such as URS, System Impact Assessment, Design Configuration/Specification, Validation Plans, Data integrity assessments, Traceability Matrices, vendor documentation, commissioning documents, including IQ/OQ/PQ, and Turnover documentation.
• Support technical commissioning and qualification documentation for laboratory equipment and software, in accordance with client’s quality standards, current Good Manufacturing Practices, (21 Code of Federal Regulations Part 11, 210, 211, and 820 level standards which apply to the equipment being validated) and national/international standards.
• Creation and management of work orders to add and/or update equipment to the client’s Computerized Maintenance Management System (CMMS).
• Manage and work collaboratively with clients’ quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities. Maintain clear and detailed records of qualification and change control activities for future compliance audits.
• Project assignments will vary by customer requirements for specific defined deliverables based on project needs and scope.

• #LI-MC1

Requirements

• Bachelor’s degree in an Engineering or Scientific field, or equivalent
• 1-3 years’ experience in GMP regulated environment
• Experience supporting, writing and executing GMP documentation and validation protocols, such as IQ/OQ/PQ documents
• Familiarity with Data Integrity principles and/or computerized systems
• Proven ability to work effectively with a team and in a client-facing environment, excellent verbal and written communication skills

Benefits

Why Verista?

• High growth potential and fast paced organization with a people-focused culture
• Competitive pay plus performance-based incentive programs
• Company paid medical premiums.
• Company paid Life, Short-Term, and Long-Term Disability insurances
• Dental & Vision insurances
• Health Savings Account
• 401(k) Retirement Plan (Employer Matching benefit)
• Paid Time Off (Rollover Option) and Holidays
• Leadership development training, career planning, and tuition reimbursement
• Team Social Activities (We have fun!)
• Employee Recognition
• Employee Referral Program
• Paid Maternity, Parental Leave and Bereavement

Verista is a leading business, technology and compliance company that enables clients to improve health and improve lives. We help clients solve their most critical and complex challenges across the GxP lifecycle, from preclinical and clinical to commercialization, manufacturing, and distribution. This experience brings together decades of knowledge, the most advanced engagement platforms, as well as transformative technologies. This allows clients to benefit from the ease, efficiency, and trust that results from working with one partner who excels across specialties.

For more information about our company, please visit us at Verista.com or follow us on