V
6364 - Lead CQV Engineer / Lead Validation Engineer
Accepting applicationsVerista · Devens, MA
Full-Time Mid_senior SicSocaiarmate
Posted
1d ago
Category
Test
Experience
Mid_senior
Country
United States
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
Lead Validation Engineer Responsibilities:
Lead CQV execution activities across multiple systems and workstreams
Coordinate daily execution priorities to recover schedule slippage and maintain timelines
Interface with QA, Engineering, and Operations to resolve issues in real time
Oversee execution of IQ/OQ protocols and operational verification activities
Support and review:
Drawing walkdowns
Equipment and component verification
Materials of Construction (MOC) and weld verification
Provide oversight for temperature mapping and validation activities
Support SIP/CIP and related cycle development activities as needed
Ensure all documentation meets GMP/GDP and audit-ready standards
Drive deviation identification, escalation, and resolution
Job Requirements:
Bachelor’s Degree or equivalent required (STEM degree, Biomedical Engineering, Chemical Engineering preferred)
8+ years of CQV/validation experience in pharma or biotech
Strong hands-on execution background with process equipment (bioreactors, filtration, chromatography, UF)
Proven experience leading validation teams or shift-based execution efforts
Strong GMP/GDP knowledge
Experience with eVal (required), ValGenesis a plus
Experience with temperature mapping (Ellab a plus)
This role requires the ability to be on-site, full-time in Devens, MA.
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.
National (US) Range: $87,780 USD - $145,307 USD
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
Show more Show less
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
Lead Validation Engineer Responsibilities:
Lead CQV execution activities across multiple systems and workstreams
Coordinate daily execution priorities to recover schedule slippage and maintain timelines
Interface with QA, Engineering, and Operations to resolve issues in real time
Oversee execution of IQ/OQ protocols and operational verification activities
Support and review:
Drawing walkdowns
Equipment and component verification
Materials of Construction (MOC) and weld verification
Provide oversight for temperature mapping and validation activities
Support SIP/CIP and related cycle development activities as needed
Ensure all documentation meets GMP/GDP and audit-ready standards
Drive deviation identification, escalation, and resolution
Job Requirements:
Bachelor’s Degree or equivalent required (STEM degree, Biomedical Engineering, Chemical Engineering preferred)
8+ years of CQV/validation experience in pharma or biotech
Strong hands-on execution background with process equipment (bioreactors, filtration, chromatography, UF)
Proven experience leading validation teams or shift-based execution efforts
Strong GMP/GDP knowledge
Experience with eVal (required), ValGenesis a plus
Experience with temperature mapping (Ellab a plus)
This role requires the ability to be on-site, full-time in Devens, MA.
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.
National (US) Range: $87,780 USD - $145,307 USD
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
Show more Show less