6097 - Senior CQV Engineer / Senior Validation Engineer
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What you'll do
- Provide engineering and CQV support for the implementation, modification, commissioning, and qualification of manufacturing equipment and systems.
- Develop a thorough understanding of equipment design, functionality, controls, operating principles, and intended use.
- Serve as a technical resource for equipment-related issues throughout design, installation, commissioning, startup, and qualification.
- Review engineering drawings and technical documentation, including P&IDs, equipment specifications, datasheets, electrical drawings, and vendor documentation.
- Support equipment design reviews and provide input regarding functionality, maintainability, operability, and qualification requirements.
- Coordinate with equipment vendors, contractors, Engineering, Manufacturing, Automation, Quality, and other project stakeholders.
- Support and/or execute equipment startup, commissioning, troubleshooting, and qualification activities.
- Identify equipment and system issues and work with project teams and vendors to drive issues through resolution.
- Support FAT, SAT, commissioning, and qualification activities as required.
- Author, review, and revise CQV and engineering documentation, including:
- User Requirements Specifications (URS)
- Commissioning protocols
What they're looking for
- Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline preferred, or equivalent relevant industry experience.
- Approximately 5+ years of experience supporting engineering, commissioning, qualification, validation, or equipment implementation within pharmaceutical, biotechnology, medical device, or another regulated manufacturing environment.
- Strong understanding of manufacturing equipment and equipment systems, including how equipment is designed, installed, operated, tested, and maintained.
- Demonstrated project engineering experience supporting equipment installation, startup, commissioning, or qualification.
- Experience working directly with equipment vendors, engineering teams, manufacturing personnel, and Quality.
- Working knowledge of CQV lifecycle activities, including FAT, SAT, commissioning, IQ, OQ, and PQ.
- Ability to read and interpret engineering drawings, equipment specifications, P&IDs, and technical documentation.
- Ability to author clear and technically accurate engineering and CQV documentation.
- Strong troubleshooting and problem-solving skills with the ability to identify and resolve equipment-related issues.
- Understanding of cGMP requirements and Good Documentation Practices.
- Strong communication, organizational, and project coordination skills.
- Ability to work independently while effectively collaborating within multidisciplinary project teams.
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
Description
Verista’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:
- Provide engineering and CQV support for the implementation, modification, commissioning, and qualification of manufacturing equipment and systems.
- Develop a thorough understanding of equipment design, functionality, controls, operating principles, and intended use.
- Serve as a technical resource for equipment-related issues throughout design, installation, commissioning, startup, and qualification.
- Review engineering drawings and technical documentation, including P&IDs, equipment specifications, datasheets, electrical drawings, and vendor documentation.
- Support equipment design reviews and provide input regarding functionality, maintainability, operability, and qualification requirements.
- Coordinate with equipment vendors, contractors, Engineering, Manufacturing, Automation, Quality, and other project stakeholders.
- Support and/or execute equipment startup, commissioning, troubleshooting, and qualification activities.
- Identify equipment and system issues and work with project teams and vendors to drive issues through resolution.
- Support FAT, SAT, commissioning, and qualification activities as required.
- Author, review, and revise CQV and engineering documentation, including:
- User Requirements Specifications (URS)
- Commissioning protocols
- IQ/OQ/PQ protocols and reports
- Risk assessments
- Traceability documentation
- Engineering studies
- Deviations and discrepancy documentation
- Turnover and closeout documentation
- Ensure commissioning and qualification activities are appropriately documented and executed in accordance with project requirements, site procedures, and cGMP expectations.
- Manage assigned engineering/CQV activities against project schedules and communicate risks, issues, and progress to project leadership.
- Provide hands-on support in the field during equipment installation, startup, testing, and qualification.
- Support investigation and resolution of technical issues encountered during commissioning and qualification.
Requirements:
- Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline preferred, or equivalent relevant industry experience.
- Approximately 5+ years of experience supporting engineering, commissioning, qualification, validation, or equipment implementation within pharmaceutical, biotechnology, medical device, or another regulated manufacturing environment.
- Strong understanding of manufacturing equipment and equipment systems, including how equipment is designed, installed, operated, tested, and maintained.
- Demonstrated project engineering experience supporting equipment installation, startup, commissioning, or qualification.
- Experience working directly with equipment vendors, engineering teams, manufacturing personnel, and Quality.
- Working knowledge of CQV lifecycle activities, including FAT, SAT, commissioning, IQ, OQ, and PQ.
- Ability to read and interpret engineering drawings, equipment specifications, P&IDs, and technical documentation.
- Ability to author clear and technically accurate engineering and CQV documentation.
- Strong troubleshooting and problem-solving skills with the ability to identify and resolve equipment-related issues.
- Understanding of cGMP requirements and Good Documentation Practices.
- Strong communication, organizational, and project coordination skills.
- Ability to work independently while effectively collaborating within multidisciplinary project teams.
- Onsite work requirement in Bloomington, IN.
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.
*Verista is an equal opportunity employer.
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
Verista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details.
For more information about our company, please visit us at Verista.com
Company
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