5139- Senior CQV Engineer - Senior Validation Engineer Kalamazoo, MI

Tbwa Chiat/Day Inc; Kalamazoo (MI); On-site; USD 70,000 - 119,000; Full time

Job summary

Join a dynamic and innovative team dedicated to empowering growth in the life sciences sector. This role involves conducting critical assessments, maintaining compliance records, and leading engineering studies to ensure the highest standards of quality and efficiency. You'll collaborate with talented professionals who are committed to making a significant impact in healthcare. With a strong focus on team culture and continuous learning, this position offers the opportunity to grow within a fast-paced environment that values your contributions. If you're ready to take on challenges and drive success, this is the perfect opportunity for you.

Benefits

Company-paid Life Insurance

Health Savings Account

Paid Time Off

Tuition Reimbursement

Team Social Activities

Employee Recognition

Paid Parental Leave

Bereavement Leave

Qualifications

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

Responsibilities

• Conduct impact and risk assessments for complex processes.
• Maintain detailed records for compliance audits.
• Design and execute engineering studies prior to validation.

Skills

Effective Communication

Problem-Solving

Critical Thinking

Organizational Skills

Team Collaboration

Education

Bachelor’s Degree

Tools

Microsoft Office

Job 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

Responsibilities:

• 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
• 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

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

Salary Range:

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.

National (US) Range: $70,491 - $118,941 USD

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.
• Supplemental Life, Hospital, Critical Illness and Legal Insurance
• Health Savings Account
• 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 is an equal opportunity employer.

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