Piper Companies is hiring: Cleaning Validation Engineer in Indianapolis

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The Cleaning Validation Engineer will join a leading global pharmaceutical company that is expanding its international presence, with plans to grow in size and production. This role supports a high-impact project focused on reducing batch changeover time and increasing operational efficiency. The Cleaning Validation Engineer will be responsible for executing cleaning validation activities, supporting CQV efforts, and collaborating with cross-functional teams to optimize manufacturing processes and ensure regulatory compliance.

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

Responsibilities

• Cleaning Validation & Compliance Oversight: Execute cleaning and sterility validation (CVSV) studies, including swabbing, sample collection, and lab submissions.
• Enter sample data into validation software and develop validation reports.
• Ensure validation protocol data meets documented acceptance criteria and regulatory standards.
• CQV & Validation Process Management: Support commissioning, qualification, and verification (CQV) of tanks, piping systems, automated equipment, filter integrity test cart, refrigerators, and freezers.
• Collaborate on IQ, OQ, and PQ protocols using Kneat software.
• Assist in filter integrity testing, temperature mapping (Ellab), and equipment qualification.
• Own and manage change controls, ensuring timely implementation and stakeholder communication.
• Lead deviation investigations and develop corrective action plans.
• Continuous Improvement & Operational Efficiency: Participate in workplace optimization and continuous improvement initiatives.
• Lead owner project management efforts including capital investment requests, scheduling, and team coordination.
• Uphold all safety and environmental standards in daily operations.

Qualifications

• Bachelor’s Degree in Engineering, Life Sciences, or a related technical field.
• Minimum 3 years of cleaning validation experience in a regulated manufacturing environment.
• CQV experience and familiarity with manufacturing floor operations highly preferred.
• Knowledge of cGMP documentation and regulatory standards.
• Strong soft skills: motivation, and ability to thrive in a fast-paced, execution-heavy environment.
• Experience with validation tools such as Kneat and Ellab.
• 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.

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.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Quality Assurance

Industries

• Business Consulting and Services

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