Contract Mfg & Process Eng (IQ/OQ/PQ) - Onsite

Pacer Group; Hopkinsville (KY); Presencial; USD 34.000 - 39.000; A tiempo parcial

Ventajas ofrecidas por este puesto de trabajo

Medical

Dental

Vision

401(k)

Descripción de la vacante

Pacer Group in Hopkinsville, KY seeks a Manufacturing & Process Engineer (Contract) to lead IQ/OQ/PQ activities and ensure regulatory compliance for pharmaceutical equipment. The role requires 3–5 years in equipment qualification with strong QA collaboration

The position is onsite with Monday–Friday hours, open-ended contract duration, and a need for immediate availability. W2 pay range is $25–$28 per hour.

Formación

• Bachelor's degree in Engineering, Life Sciences, or related field.
• 3-5 years of experience in equipment qualification or validation.
• Strong knowledge of IQ/OQ/PQ processes.
• Experience with cGMP, FDA regulations, and validation documentation.
• Strong analytical, communication, and problem-solving skills.
• Flexible with working hours and travel.

Responsabilidades

• Develop, review, and execute IQ/OQ/PQ protocols.
• Ensure equipment installation, operation, and performance meet specifications.
• Prepare qualification plans, test reports, and summary documentation.
• Identify, document, and resolve deviations.
• Perform requalification activities and verify corrective actions.
• Ensure compliance with cGMP, FDA, and quality standards.
• Collaborate with Engineering, Quality, and Manufacturing teams.
• Support qualification activities based on production schedules and travel requirements.

Conocimientos

Equipment qualification experience

IQ/OQ/PQ processes

Analytical skills

Communication skills

Problem-solving

Travel flexibility

Immediate availability

cGMP/FDA knowledge

Educación

Bachelor's degree in Engineering or Life Sciences

Descripción del empleo

Pacer Group in Hopkinsville, KY seeks a Manufacturing & Process Engineer (Contract) to lead IQ/OQ/PQ activities and ensure regulatory compliance for pharmaceutical equipment. The role requires 3–5 years in equipment qualification with strong QA collaboration

The position is onsite with Monday–Friday hours, open-ended contract duration, and a need for immediate availability. W2 pay range is $25–$28 per hour.