Filling CQV Engineer Sr.

The Filling CQV Engineer Sr. will join a leading global pharmaceutical company that is rapidly expanding its international presence, with plans to double in both size and production in the coming years. This role supports a Manufacturing Facility in Indianapolis, Indiana, and focuses on commissioning, qualification, and validation (CQV) of aseptic filling equipment. The engineer will be responsible for protocol development, IOQ execution, and airflow testing, contributing to a high-performing team with a strong track record of success.

This position will follow standard hours: Monday through Friday, 8:00 AM to 5:00 PM, onsite in Indianapolis, Indiana.

Responsibilities of the Filling CQV Engineer Sr.:

• CQV & Protocol Development:
• Lead CQV efforts for a Cytiva Aseptic Filler (no upstream washer or tunnel).
• Execute IOQ protocols and airflow testing; potential involvement in design qualification.
• Develop protocols including user requirements and component assessments.
• Collaborate with subject matter experts to ensure all inputs are captured for comprehensive protocol creation.
• Maintain high standards of quality, compliance, and execution in a regulated environment.
• Continuous Improvement & Operational Support:
• Participate in continuous improvement initiatives and support site operations.
• Communicate effectively with stakeholders and contribute to team meetings and planning.
• Uphold all safety and environmental standards in daily operations.

Qualifications of the Filling CQV Engineer Sr.:

• Bachelor’s Degree in Engineering or equivalent relevant experience.
• Minimum 5 years of CQV experience, including protocol development and component assessments.
• Strong understanding of user requirements and validation documentation.
• Familiarity with cGMP standards and regulated manufacturing environments.
• Excellent soft skills: hunger, motivation, and ability to thrive in a fast-paced, execution-heavy role.
• Strong analytical, problem-solving, and organizational skills.

Compensation & Benefits:

• Competitive hourly rate: $60-80/hr, based on experience.
• Full benefits package including Medical, Dental, Vision, 401K, PTO, Sick Leave, and Holidays.

Key Words:

CQV Engineer, Filling Equipment, IOQ, Protocol Development, Component Assessment, Aseptic Filling, cGMP Compliance, Root Cause Analysis, Change Control, Technical Documentation, Quality Assurance, Airflow Testing, Design Qualification

If you are passionate about ensuring high standards in validation, compliance, and process improvement, we encourage you to apply today!

This job opens for applications on 8/11. Applications for this job will be accepted for at least 30 days from the posting date.

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