Manufacturing Associate(GMP)

Intellectt Inc; Harmans (MD); On-site; USD 45,000 - 65,000; Full time

Job summary

A leading company in Medical Equipment and Pharmaceutical Manufacturing is seeking a Manufacturing Associate II for a contract role in Harmans, MD. The successful candidate will execute manufacturing operations, troubleshoot process issues, and support GMP projects. This position requires strong communication and problem-solving skills, along with relevant experience in biologics manufacturing.

Qualifications

• 4-7 years experience in GMP biologics manufacturing with a HS diploma.
• 2-4 years experience with an Associate's degree or 1-3 years with a Bachelor's degree.
• Strong knowledge of cGMP and manufacturing principles.

Responsibilities

• Execute and document manufacturing operations per SOPs and Batch Production Records.
• Troubleshoot equipment/process issues and support deviation investigations.
• Generate and revise SOPs, BPRs, and other GMP documents.

Skills

Communication

Teamwork

Problem Solving

Education

High School Diploma

Associate's Degree

Bachelor's Degree

Job description

Job Title: Manufacturing Associate II – (GMP)

Location: Harmans, MD

Duration: 3-6 months

What You'll Do:

• Execute and document manufacturing operations per SOPs and Batch Production Records (BPRs)
• Troubleshoot equipment/process issues and collaborate with Facilities/Validation teams
• Support deviation investigations, CAPAs, and process improvements
• Assist in tech transfer and onboarding of new GMP projects
• Generate and revise SOPs, BPRs, and other GMP documents
• Interact with clients during manufacturing campaigns; may escort person-in-plant (PIP)
• Participate in facility expansions, equipment validation, and cross-functional collaborations

Qualifications:

• HS diploma + 4–7 yrs, Associate’s + 2–4 yrs, or Bachelor’s + 1–3 yrs in GMP biologics manufacturing (upstream or downstream)
• Strong knowledge of cGMP, manufacturing principles, and documentation standards
• Excellent communication, teamwork, and problem-solving skills
• Able to lift up to 40 lbs., stand/walk frequently, and work shifts/weekends as needed

Additional Information:

• Seniority level: Associate
• Employment type: Contract
• Job function: Manufacturing
• Industries: Medical Equipment Manufacturing and Pharmaceutical Manufacturing