Senior CQV Engineer / Lead Validation Engineer - 5322

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

Lead CQV Engineer Responsibilities:

• Coordinate scheduling and execute OPQ Validation Protocol
• Validation Protocol for Cycle Migration and Bowie Dick Addition to Autoclave
• OQ test cases included:

1. Signature Log
2. Change Control/QA Controlled Equipment List
3. Standard Operating Procedures
4. Identification of Test Equipment
5. Identification of Materials
6. Calibration of Equipment and Equipment Components Verfication
7. Cycle Configuration and Addition (4 cycles to be added to autoclave)
8. Bowie Dick Test (Triplicate)
9. Empty Chamber Temperature Uniformity Study 4x (1 per added cycle)

• PQ test cases

1. Heat Penetration Study:

• 3x studies for M15 liquid load configuration
• 1x study for MAV1 liquid load configuration
• 1x study for MAV4 liquid load configuration
• 1x study for MAV5 liquid load configuration
• 1x study for MAV12 liquid load configuration
• 3x studies for M10 liquid load configuration
• 3x studies on variable decon load
• Standard Operation Procedure Revision (Redline Submission)

• PQ test cases

1. Heat Penetration Study

• 1x study on existing cycle 1 equipment and supplies
• Complete Validation Summary Report
• Managing the responsibilities on multiple simultaneous projects and/or clients
• Driving the activities as client facing leader and responsible party
• Act as the defined point of escalation and issue management on client projects
• Designing validation plans
• Fluent in working with equipment OEMs and installation vendors
• Maintaining (and ensuring the team maintains) clear, detailed records of qualification and validation, and change control activities for future compliance audits
• Authoring, editing, and executing technical commissioning, qualification and validation documentation for standard equipment/systems/ software, and processes as part of team as directed by the project leader
• Running test scripts and documenting results
• Adherence with project schedule for all assigned activities
• Maintaining clear, detailed records qualification and validation
• Developing, reviewing, and executing testing documentation
• Making recommendations for design or process modification based on test results when executing test scripts
• General understanding of capital equipment implementation and process knowledge
• Understanding validation documents, URS, IQ, OQ, PQ

Requirements

• Demonstrated experience in Commissioning & Validation activities covering URS (GMP equipment)
• Demonstrated experience authoring and executing FAT, SAT, IOQ, CSV Protocols
• Must be willing to work onsite in Athens, GA
• 6-10+ years of demonstrated CQV experience in GMP regulated environments
• 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
• Proven attention to detail and organization in project work
• Capable of working on assigned tasks without mentorship
• GMP and Good Documentation Practice training (may be completed at onboarding)
• 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

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.

$87,780-134,153

*Verista is an equal opportunity employer.