6518 - Service Order CQV Engineer / Validation Engineer

Verista; Indianapolis (IN); On-site; USD 70,000 - 103,000; Full time

Benefits offered by this job

Competitive pay

Health insurance

401(k) Retirement Plan

Paid Time Off

Tuition Reimbursement

Life Insurance

Disability Insurance

Employee Recognition

Job summary

Verista, a leader in life sciences CQV services, seeks a CQV Engineer to deliver commissioning, qualification, and verification on large capital projects. You will author and execute validation documentation, review P&IDs, and work with clients’ quality teams to resolve deviations.

The role requires a bachelor’s degree in engineering or science and 1–3 years in GMP environments, with familiarity of FDA ISPE and GDP standards. US-based compensation is provided with comprehensive benefits.

Qualifications

• Bachelor’s degree in Engineering or Science field
• 1–3 years’ GMP regulated environment experience
• Experience with FAT/IQ/OQ/PQ validation and change controls
• Knowledge of FDA, ISPE guidelines, and ISO GDP in pharma environment
• ASTM-E2500 knowledge

Responsibilities

• Provide technical CQV expertise on large capital projects ensuring CQV deliverables are delivered consistently and efficiently.
• Author and execute commissioning and qualification documents per quality standards (GMP, 21 CFR 210/211/820).
• Verify system drawings, review as-built P&IDs and I&C drawings with electrical support.
• Collaborate with clients’ quality representatives to complete deviation investigations and change control activities.
• Project assignments vary by customer requirements for defined deliverables.

Skills

CQV Experience

GMP Knowledge

Regulatory Knowledge

Automated Equipment

Education

Bachelor’s degree in Engineering or Science

Job 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

Service Order CQV Engineer Responsibilities:

• Provide technical CQV (commissioning, qualification, and verification) expertise on large capital projects involving new or modified equipment, facilities, and utilities ensuring CQV aspects are delivered consistently and efficiently. Includes authoring and executing documents such as URS, System boundary definition, Risk Assessment, Traceability matrices, Design Qualification, Start Up and Debug documentation, commissioning documents, including FAT and SAT, IQ/OQ/PQ, Turnover documentation
• Author and execute technical commissioning and qualification documentation for complex, automated equipment, and processes, in accordance with client’s quality standards, current Good Manufacturing Practices, (21 Code of Federal Regulations Part 210, 211 and 820 level standards which apply to the equipment and product being validated) and national/international standards
• Verify system drawings including ability to review and as-build P&IDs and I&C drawings as well as verifying electrical schematics with electrical engineering support
• Manage and work collaboratively with clients’ quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities. Maintain clear and detailed records of qualification and change control activities for future compliance audits
• Project assignments will vary by customer requirements for specific defined deliverables based on project needs and scope

Requirements:

• A minimum of a Bachelor’s degree in an Engineering or Scientific degree
• 1-3 years’ experience in GMP regulated environment
• Technical understanding and experience with automated equipment for manufacturing, device assembly, and packaging (PLCs, HMIs, PC based controls)
• Direct experience authoring/editing/executing validation documents for equipment/facilities/utilities including FAT, IQ, OQ, PQ and change controls
• Intermediate to Expert (Senior and Lead) knowledge of FDA regulations, ISPE guidelines and ISO standards including Good Documentation Practice (GDP) in pharmaceutical environment
• ASTM-E2500

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 USD - $102,623 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