5139- Senior CQV Engineer - Senior Validation Engineer

Verista; Kalamazoo (MI); On-site; USD 70,000 - 119,000; Full time

Job summary

An established industry player in the life sciences sector is seeking a Senior CQV Engineer to join their dynamic team. This role offers an exciting opportunity to work on innovative projects that tackle critical healthcare challenges. As a Senior CQV Engineer, you will design validation plans, conduct risk assessments, and ensure compliance through meticulous documentation. The company fosters a supportive culture that empowers its employees to thrive and grow, making it an ideal place for professionals eager to make a significant impact. If you are passionate about advancing life sciences and possess strong problem-solving skills, this position is perfect for you.

Benefits

Medical, Dental & Vision Insurance

401(k) Retirement Plan

Tuition Reimbursement

Paid Time Off

Employee Recognition

Paid Parental Leave

Team Social Activities

Company-paid Disability Insurance

Qualifications

• 4-6 years of experience in CQV activities specific to Process Equipment.
• Ability to mentor and guide less experienced team members.

Responsibilities

• Designing validation plans and conducting risk assessments.
• Maintaining detailed records of qualification and validation activities.

Skills

Communication Skills

Problem-Solving Skills

Attention to Detail

Time Management

Team Collaboration

Education

Bachelor's Degree

Tools

Microsoft Office

Job description

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Description

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
  
  

Senior CQV Engineer Responsibilities

• Designing validation plans
• Conducting and documenting impact and risk assessments with a full understanding of equipment/system/software operation and ability to assess direct, indirect, and no impact systems and functions within complex processes
• Maintaining (and ensuring the team maintains) clear, detailed records of qualification and validation, and change control activities for future compliance audits
• Designing and executing engineering studies for critical process parameter definition and verification prior to validation
• 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 Kalamazoo, MI
• Bachelor’s Degree or equivalent required
• Ability to mentor and guide less experienced team members
• Ability to communicate effectively with clients
• Proven ability to identify areas of business expansion and report to management team for follow-up
• Obvious business maturity and interpersonal skills to be able to effectively communicate and collaborate
• Experience and capability of effectively communicating requirements (written and orally) with rationale to different levels of the client’s organization
• 4 - 6 years of demonstrated role relevant experience
• Demonstrated experience in leading CQV activities specific to Process Equipment
• 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
  
  

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—$118,941 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

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Pharmaceutical Manufacturing

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