Onsite CQV Principal Engineer - Bloomington, IN

Simtra US LLC; Bloomington (IN); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Medical & Dental

401(k)

Paid Time Off

Parental Leave

Education Assistance

Employee Ownership

Disability Insurance

Voluntary Insurance

Onsite Campus Amenities

Job summary

Simtra US LLC in Bloomington, IN seeks a CQV Principal Engineer to lead commissioning, qualification and validation for pharma manufacturing equipment. You will author and review documentation, manage CAPAs, and mentor engineers across teams.

Cross-functional collaboration with Quality, EHS, Maintenance and Manufacturing is essential; this is a 100% onsite role requiring a BS in engineering or life sciences and 10+ years in pharma/biotech. Strong communication and project skills are required.

Qualifications

• Excellent oral and written communication with cross-functional influence.
• Experience in CQV, GMP, and regulatory guidelines.
• Ability to manage multiple priorities in a fast-paced environment.

Responsibilities

• Lead commissioning, qualification, and validation activities for CQV scope.
• Author, review, and approve engineering documentation and CAPAs.
• Supervise Validation Maintenance/Periodic Review program.
• Facilitate governance, track risks, and report progress to leadership.
• Support regulatory inspections and client audits; drive corrective actions.
• Collaborate with internal departments and external engineering firms.

Skills

Regulatory alignment

Cross-functional collaboration

Strong communication

Project management

Documentation expertise

Education

BS in Engineering/Life Sciences or related

Job description

Simtra US LLC in Bloomington, IN seeks a CQV Principal Engineer to lead commissioning, qualification and validation for pharma manufacturing equipment. You will author and review documentation, manage CAPAs, and mentor engineers across teams.

Cross-functional collaboration with Quality, EHS, Maintenance and Manufacturing is essential; this is a 100% onsite role requiring a BS in engineering or life sciences and 10+ years in pharma/biotech. Strong communication and project skills are required.