6458 - Senior CQV Engineer / Senior Validation Engineer

Senior CQV Engineer

Designing validation plans
Conducting and documenting impact and risk assessments with a full understanding of equipment/system/software operation and ability to assess direct, indirect, and no impact systems and functions within complex processes
Maintaining (and ensuring the team maintains) clear, detailed records of qualification and validation, and change control activities for future compliance audits
Designing and executing engineering studies for critical process parameter definition and verification prior to validation
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
Documenting impact and risk assessments as part of a team
Completing user interface testing, software verification, and complete alarm testing on automated systems
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

• Must be able/willing to work onsite in the Boston metropolitan area
• Willing to meet potential future travel requirements (10-50%)
• Bachelor’s Degree or equivalent required
• Ability to mentor and guide less experienced team members
• Ability to communicate effectively with clients
• Proven ability to identify areas of business expansion and report to management team for follow-up
• 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
• 4 - 6 years of demonstrated role relevant experience
• Demonstrated experience in leading CQV activities specific to pharmaceutical manufacturing requirements
• 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
• Strong 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

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

About the Role

Empowering growth and innovation within the scientific community
Helping researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges

Qualifications

Empowering and supporting our colleagues
Commitment to client success at every turn
Courage to do the right thing
Inclusive environment where our colleagues feel respected, engaged, and challenged
Continuous acquisition of new skills and learning from experiences to enhance collective expertise

Skills

Empowering and supporting our colleagues
Commitment to client success at every turn
Courage to do the right thing
Inclusive environment where our colleagues feel respected, engaged, and challenged
Continuous acquisition of new skills and learning from experiences to enhance collective expertise

Pay

*Verista is an equal opportunity employer.

National (US) Range: $70,491 USD - $109,900 USD

This salary range is subject to change and may be modified in the future.

Benefits

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