Senior CQV Engineer – Pharma Validation Leader

Simtrabps; Bloomington (IN); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Savings Plan with a

Time Off Program

Adoption Reimbursement Program

Education Assistance Program

Employee Assistance Program

Onsite Campus Amenities

Job summary

Simtra BioPharma Solutions is seeking a CQV Principal Engineer for the Bloomington, Indiana facility. The role focuses on creating and maintaining best practices for CQV engineering documentation and equipment lifecycle management, working with Quality, EHS, maintenance, and manufacturing, reporting to the Director of Engineering.

The position is 100% onsite in Bloomington, Indiana, with responsibilities spanning cross-functional leadership, training, and regulatory readiness to support client

Qualifications

• BS degree in Engineering, Life Sciences, or related technical field.
• 10+ years experience in pharmaceutical/biotech industry 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

• Partners cross-functionally across Engineering, Maintenance, and Quality to ensure Engineering practices are compliant with procedures and Regulatory guidelines
• Serve as SME for Commissioning, Qualification, and Validation. Develops and delivers training to Engineers and applicable team members
• Authors, reviews, and approves Engineering documentation (protocols, reports, deviations, change controls, and CAPAs related to CQV scope)
• Manages team of professionals responsible for Validation Maintenance/Periodic Review program. Facilitates governance and tracks and reports progress, risks, and resource needs to leadership.
• Supports regulatory inspections and client audits. Drives and maintains Audit Readiness and leads corrective actions to closure without repeat occurrences
• Participates/collaborates with internal departments and external engineering firms in feasibility assessments, concept design, basic design and detail design

Skills

Excellent oral and written comms

Influence cross-functional teams

Organizational and planning skills

Project tracking skills

Education

BS degree in Engineering, Life Sciences, or related technical field

Job description

Simtra BioPharma Solutions is seeking a CQV Principal Engineer for the Bloomington, Indiana facility. The role focuses on creating and maintaining best practices for CQV engineering documentation and equipment lifecycle management, working with Quality, EHS, maintenance, and manufacturing, reporting to the Director of Engineering.

The position is 100% onsite in Bloomington, Indiana, with responsibilities spanning cross-functional leadership, training, and regulatory readiness to support client