Lead CQV Engineer – Validation & Compliance

Simtra BioPharma Solutions; Bloomington (IN); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Savings Plan with Company Match

Paid Time Off

Education Assistance Program

Job summary

A leading pharmaceutical company in Bloomington, Indiana is seeking a Validation Engineer II to join their Engineering team. The candidate will be responsible for managing commissioning, qualification, and validation processes, ensuring compliance with industry standards. Key qualifications include a BS degree in Engineering or Science and 2+ years of relevant experience. This role is fully onsite and offers a dynamic environment focused on quality and continuous improvement.

Qualifications

• 2+ years experience in commissioning, qualification, and validation in a regulated industry.
• Familiarity with ISPE Baseline Guide 5.
• Experience managing multiple projects in different stages at the same time.

Responsibilities

• Write and execute protocols to ensure compliance.
• Manage change controls and assess validation impacts.
• Continuously interact with management across teams.

Skills

Technical writing skills

Project management

Communication

Problem-solving

Education

BS degree in an Engineering or Science discipline

Tools

Microsoft Office Suite

Job description

A leading pharmaceutical company in Bloomington, Indiana is seeking a Validation Engineer II to join their Engineering team. The candidate will be responsible for managing commissioning, qualification, and validation processes, ensuring compliance with industry standards. Key qualifications include a BS degree in Engineering or Science and 2+ years of relevant experience. This role is fully onsite and offers a dynamic environment focused on quality and continuous improvement.