Manufacturing & Process Engineer

Pacer Group; Hopkinsville (KY); On-site; USD 34,000 - 39,000; Part time

Benefits offered by this job

Medical

Dental

Vision

401(k)

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Equipment qualification experience

IQ/OQ/PQ processes

Analytical skills

Communication skills

Problem-solving

Travel flexibility

Immediate availability

cGMP/FDA knowledge

Education

Bachelor's degree in Engineering or Life Sciences

Job description

Job role: Manufacturing & Process Engineer

Location: Hopkinsville, KY

Work Arrangement: Onsite

Working Hours: Monday-Friday

Pay Rate: $25-$28/hr on W2

Domain: Pharma

Employment Type: Contract

Duration: 3 Month CTH

Application Deadline: Open until Filled

Summary

We are seeking a C&Q Engineer with 3-5 years of experience in equipment qualification and validation. The candidate will oversee IQ/OQ/PQ activities, ensuring equipment and systems comply with cGMP, FDA, and regulatory requirements.

Responsibilities

• Develop, review, and execute IQ/OQ/PQ protocols.
• Ensure equipment installation, operation, and performance meet required 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.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a 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 open to travel.
• Immediate availability preferred.
• Background check is mandatory.
• U.S. Citizens and Green Card holders preferred; other valid work authorizations may be considered.

• Medical | Dental | Vision | 401(k)

EEOC Compliance:

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment.

Disclaimer:

AI Usage Policy: Pacer Group uses AI to assist in screening applications. Final hiring decisions are made by human recruiters based on qualifications and experience.