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6020 - CQV Engineer / Validation Engineer

Boston, MA

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:

  • Execute Commissioning, Qualification and Validation activities for Cell and Gene Therapies Facility
  • Draft and implement Quality System documentation designed to establish good validation practices within the organization
  • Author URS, IQ, OQ and PQ protocols and execute them in compliance with GDP guidelines and internal quality standards
  • Support all stages of qualification of Analytical Instrument and Manufacturing equipment
  • Support all stages of qualification of automated manufacturing equipment
  • Conduct Analytical Instrumentation Qualifications in accordance with USP <1058>
  • Conduct Automation Assessments to ensure compliance with 21 CFR Part 11
  • Coordinate with vendor personnel and stakeholders to schedule and execute test plans and CQV activities
  • Author documents and support process validation related activities including aseptic process simulations (APS), process performance qualification, material qualifications, etc.
  • Develop cycles for sterilization processes and validate them as required

Requirements:

  • Must be willing to work onsite in Boston, MA
  • Bachelor’s Degree in Engineering or related discipline required
  • 3+ years experience in engineering and/or project management in Clean (Qualified) & Black (Non-Qualified) Utility Verifications plus Facility systems Qualifications
  • Experience with large scale small molecule and biologic manufacturing equipment including: tanks, skids, WFI, autoclaves, filling lines, packaging equipment, etc.
  • Ability to mentor and guide less experienced team members
  • Experience and capability of effectively communicating requirements (written and orally) with rationale to different levels of the client’s organization
  • Demonstrated experience in leading CQV activities specific to Process Equipment
  • Proficiency using PC and Microsoft Office tools
  • Ability to work as part of a team
  • Strong problem-solving and critical thinking skills
  • Strong attention to detail
  • This role *may* include weekends and/or “off-shifts” for APS execution (as-needed) - but will not exceed 40 hours/week in total

 

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

$70,491 - $99,899 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

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