6624 - CQV Engineer

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

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

$79,695—$104,439 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

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