Lead CQV / Lead Validation Engineer- 4873

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 Validation Engineer Responsibilities :

• Serve as the primary Commissioning & Verification (C&V) Subject Matter Expert for one of four project work streams. Commissioning and Verification (aka Qualification) will follow the ASTM E2500 standard.
• Effectively interact with leadership and partner with C&V Lead, Engineering Project Management, Automation, Maintenance, Operations, and Quality stakeholders to establish priorities and define the commissioning & verification requirements for the assigned workstream.

This would include documentation of critical aspects, risk assessments, verification testing strategy, and acceptance criteria.

• Review of technical specification documents, drawings, and vendor design submittals (including FAT, SAT, IQ / OQ), with a specific focus on GMP-critical aspects and impact on commissioning & verification.
• Review and assess vendor documentation and executed testing (e.g. FAT, SAT) for adherence to GMP and project requirements.
• Lead and participate in development and execution of complete verification documentation in accordance with Pfizer Quality Standards, cGMP requirements, and approved verification requirements / strategy related to the assigned work stream.
• Collaborate with other work stream leads to ensure effective integrated verification strategy of integrated systems and equipment.
• Provide or arrange for development of complete verification documentation in accordance with Pfizer Quality Standards and cGMP requirements for assigned work stream.
• Collaborate with matrix organization to optimize Change Control implementation and management.
• Maintain a working familiarity with current industry best practices and cGMP requirements. Maintain technical skills in the latest techniques for project management and pharmaceutical processing technology.
• Assist C&V Lead with the preparation of C&V status reports : include descriptions, justifications, cost estimates, budgets, schedules, analysis of alternatives, verification requirements, and other required information.

Requirements

• Must be willing to work onsite in Kalamazoo, MI
• Bachelor of Science in Technical Field (engineering, life science, or equivalent) from accredited institution.
• Minimum 4 years technical experience, 10+ preferred.
• Experience in a pharmaceutical / FDA-regulated manufacturing environment. A solid working knowledge of cGMP and facility / equipment validation requirements.
• Communication Skills : Excellent oral and written communication skills, including presentations.
• Ability to write clearly, concisely, and persuasively in a professional environment.
• Demonstrated ability to interact effectively with all levels of the organization.
• Demonstrated understanding of risk-based approach to commissioning & qualification.
• Experience with testing of automated manufacturing equipment / systems (e.g., PLC-controlled).
• 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.

$85,000 - $129,826

• Verista is an equal opportunity employer.
6 days ago