6460 - Senior CQV Engineer / Senior Validation Engineer
Senior CQV Engineer designs and executes validation plans for pharmaceutical manufacturing systems, ensuring compliance with GMP standards and documenting qualification activities.
- Compensation
- $70.5K–$109.9K / yr
- Location
- Durham, NC (RTP area)
- Work setup
- Not specified
- Seniority
- Senior
- Employment
- Not specified
- Experience
- 4+ years
- Category
- Industrial engineering
- Posted
Skills
Must have
- Must be able/willing to work onsite in the Raleigh/Durham metropolitan area
- Must be 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
- 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
Full description
DescriptionVerista’s 500 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
Senior CQV Engineer Responsibilities:
- 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