Manufacturing Associate

Job Title: Manufacturing Associate

Duration: 3-6 Months Contract

Location: Harmans, MD

Optional Shift Timings: 

07:00 a.m. - 07:00 p.m. (2-2-3 Rotation Schedule)

07:00 p.m. - 07:00 a.m. (2-2-3 Rotation Schedule)

Job Description:

The Manufacturing Associate I perform and documents cGMP activities to support upstream or downstream production areas and operations. This involves operation of process equipment, execution of validation protocols, completion of cGMP documents, creating/ revising cGMP documents and other assignments as directed.

Shift work and/or weekend work may be required at times.

Key Responsibilities:

• Performs Processing Steps and/or Manufacturing Support activities, monitoring process against the batch record.
• Documents/Records cGMP data and information for processing steps and/or equipment activities, following standard operating procedures. Key documentation includes batch records and equipment logbooks.
• Completes /reviews validation protocols, deviation reports, change controls in accordance with cGMP’s.
• Performs the preparation of small and large volume media and buffer solutions, filtration, and transfer of product.
• Operates bench top equipment including pH, conductivity, osmo meters, pumps, tubing welders, filter integrity testers etc.
• Dispensing, labeling, transfer/staging of raw materials and parts.
• Assembly/disassembly, cleaning and sterilization of components, parts, and equipment.
• Maintaining equipment, area, and cleaning logbooks. Cleaning sanitizing production rooms and equipment.
• Stocking production and cleaning supplies.
• May author/ review/improve SOP’s, batch records, protocols, and technical reports.
• Proficient and knowledgeable in the operation and basic troubleshooting of at least one manufacturing area.
• Other duties as assigned.

Position Requirements:

• High School Diploma with a minimum of 2-4 years GMP Manufacturing experience.
• OR Certificate and/or associate degree in a scientific, engineering or biotechnology discipline with a minimum of 0-2 years related experience; coursework with biotechnology focus highly desirable,
• OR Bachelor’s Degree (BS/BA) from an accredited college or university with an emphasis in a scientific or engineering discipline and a minimum of 0-1 years relevant experience.
• Basic knowledge of current Good Manufacturing Practices (cGMP’s). Working knowledge of all relevant safety procedures within the company. General understanding of most areas in Manufacturing and supporting functional groups.
• Familiar with or experience with cGMP Biotech or Pharmaceutical operations.