Senior CQV Engineer - Pharma Validation Leader

Simtra BioPharma Solutions; Bloomington (IN); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Medical & Dental Coverage

Flexible Spending Accounts

Life and AD&D Insurance

401(k) Retirement Savings Plan with 회사

Time Off Program

Paid Holidays

Paid Time Off

Paid Parental Leave and more

Education Assistance Program

Employee Assistance Program

Employee Ownership Plan

Short and Long-Term Disability

Vision Coverage

Identity Theft Protection

Onsite Campus Amenities

Job summary

Simtra BioPharma Solutions in Bloomington, Indiana seeks a Commissioning, Qualification, and Validation (CQV) Principal Engineer to define and maintain engineering documentation and life cycle management practices for CQV within pharma manufacturing.

The role collaborates with Quality, EHS, Maintenance and Manufacturing, reports to the Director of Engineering, and is 100% onsite at the Bloomington facility. Strong leadership and regulatory experience are required.

Qualifications

• BS degree in Engineering, Life Sciences, or related field.
• 10+ years in pharma/biotech preferred.
• Excellent oral and written communication skills with the ability to influence cross-functional teams.
• Strong organizational, planning, and project tracking skills.
• Ability to manage multiple priorities in a fast-paced environment.

Responsibilities

• Partner across Engineering, Maintenance, and Quality to ensure CQV practices comply with procedures and regulations.
• Serve as SME for CQV and deliver training to engineers and team members.
• Author, review, and approve engineering documentation (protocols, reports, deviations, change controls, CAPAs).
• Manage a team responsible for Validation Maintenance/Periodic Review program and report progress to leadership.
• Support regulatory inspections and client audits; drive audit readiness and closure of CAPAs.
• Collaborate with internal departments and external engineering firms in feasibility, design, and detailing.

Skills

Communication

Cross-functional teamwork

Organization

Project management

Education

BS degree in Engineering or Life Sciences

Job description

Simtra BioPharma Solutions in Bloomington, Indiana seeks a Commissioning, Qualification, and Validation (CQV) Principal Engineer to define and maintain engineering documentation and life cycle management practices for CQV within pharma manufacturing.

The role collaborates with Quality, EHS, Maintenance and Manufacturing, reports to the Director of Engineering, and is 100% onsite at the Bloomington facility. Strong leadership and regulatory experience are required.