6624 - CQV Engineer

veristainc; Portland (ME); On-site; USD 80,000 - 104,000; Full time

Benefits offered by this job

Life Insurance

Short-Term Disability

Long-Term Disability

Medical Insurance

Dental Insurance

Vision Insurance

Health Savings Account

401(k) Plan

Paid Time Off

Holidays

Tuition Reimbursement

Parental Leave

Bereavement Leave

Employee Referral Program

Team Social Activities

Commuter Benefits

Job summary

Verista seeks a Validation/CQV Engineer to author, edit, and execute qualification and validation documentation for new equipment and processes in NPI projects. You will support testing, changeovers, and line readiness, ensuring audit-ready records and on-time delivery.

The role requires a technical degree and 1–3 years in validation or testing, with GMP/GDP training and on-site work in Portland, ME. Collaboration with cross-functional teams is essential, with a focus on quality and

Qualifications

• Bachelor's degree in Engineering, Science, or a related technical field.
• 1–3 years of experience in supporting validation, qualification, or testing activities; internship or co‑op experience counted.
• Experience in or supporting NPI, tech transfer, or new equipment/line introductions in pharmaceutical, medical device, or regulated packaging operations.
• Ability to read and interpret technical schematics and drawings; willingness to learn quickly.
• GMP and GDP training required.
• Proficiency with PC and Microsoft Office tools, including intermediate Word skills for authoring and editing large technical documents (styles, tables, contents, track changes).
• Strong problem‑solving, critical thinking, attention to detail, organization, and time management.
• Strong interpersonal and communication skills; ability to work well in a team.
• Willingness to be on-site, full-time in Portland, ME.

Responsibilities

• Author, edit, and execute commissioning, qualification, and validation documentation for new equipment, systems, software, and processes introduced for NPI projects.
• Execute approved test scripts and document results per GDP; note discrepancies for review.
• Support installation verification, FAT/SAT, and operational testing of new equipment and line changes.
• Support product changeovers and line readiness activities to enable on-schedule product introductions.
• Maintain audit-ready qualification and validation records to support NPI launch readiness.
• Meet project schedules; communicate progress, risks, and timelines to the project leader.
• Collaborate with NPI project teams, Engineering, Automation, Quality, and vendors to resolve test issues.

Skills

GMP Training

GDP Documentation

MS Office Proficiency

Attention to Detail

Communication Skills

Team Collaboration

Education

Bachelors in Engineering/Science

Tools

Microsoft Word

Microsoft Office

Job 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

Validation/CQV Engineer Responsibilities:

• Author, edit, and execute commissioning, qualification, and validation documentation (protocols, test scripts, and summary reports) for new equipment, systems, software, and processes introduced for NPI projects, as directed by the project leader
• Execute approved test scripts, record results accurately in line with Good Documentation Practices (GDP), and document discrepancies for review and resolution
• Support installation verification, FAT/SAT, and operational testing of new equipment and line modifications, confirming components against specifications and approved drawings
• Support product changeovers and line readiness activities so new products can be introduced on schedule
• Maintain clear, detailed, audit-ready qualification and validation records that support NPI launch readiness
• Meet the project schedule for all assigned activities, communicating progress, risks, and timeline impacts to the project leader
• Collaborate with NPI project teams, Engineering, Automation, Quality, and vendors to resolve test issues and keep documentation accurate and current

Requirements:

• Bachelor's degree in Engineering, Science, or a related technical field
• 1-3 years of experience supporting validation, qualification, or testing activities; internship or co-op experience will be considered
• Experience in or supporting NPI, tech transfer, or new equipment and line introductions in pharmaceutical, medical device, combination product, or regulated packaging operations
• Ability to read and interpret technical schematics and drawings, or willingness to learn quickly
• GMP and Good Documentation Practice training
• Proficiency with PC and Microsoft Office tools, including intermediate Word skills for authoring and editing large technical documents (styles, tables, tables of contents, track changes)
• Strong problem-solving, critical thinking, attention to detail, organization, and time management skills
• Strong interpersonal and communication skills, with the ability to explain issues clearly and concisely and work effectively as part of a team
• Willingness to be on-site, full‑time in Portland, ME

National (US) Range

$79,695 - $104,439 USD

*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

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For more information about our company, please visit us at Verista.com