CQV Engineer (New Grad)

Reposted 8 Days Ago
Be an Early Applicant
Portland, ME
In-Office
Entry level
Pharmaceutical
The Role
The CQV Engineer will document, validate, and test equipment and systems, adhering to project schedules while maintaining compliance with regulations.
Summary Generated by Built In

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

CQV Engineer Responsibilities:

  • New or recent graduates are encouraged to apply
  • 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
  • General understanding of capital equipment implementation and process knowledge
  • Understanding validation documents, URS, IQ, OQ, PQ

Requirements:

  • Must be willing to work onsite in Portland, ME.
  • Bachelor’s or equivalent STEM degree required (Biomedical Engineer, Chemical Engineer, etc.)
  • Demonstrated experience in leading CQV activities specific to Process Equipment (internship experience preferred)
  • 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


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

Top Skills

Gmp
Good Documentation Practice
Microsoft Office Suite
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The Company
HQ: Fishers, IN
402 Employees
Year Founded: 2020

What We Do

Verista is a leading business and technology consultancy firm that provides systems, compliance, validation and quality solutions to life science companies - enabling them to improve health and improve lives. We help clients solve their most critical and complex challenges across the GxP lifecycle, from preclinical and clinical to commercialization, manufacturing and distribution – bringing together decades of knowledge, the most advanced engagement platforms and transformative technologies. This allows clients to benefit from the ease, efficiency and trust that results from working with one partner who excels across specialties. Verista’s clients trust the company’s 650+ experts to deliver consistent, safe, and high-quality results across the product development lifecycle. Verista is based in Fishers, Indiana, Wayne, Pennsylvania, Westford, Massachusetts, and San Mateo, California. For more information, visit www.verista.com

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