Manufacturing Associate

Mindlance; Harmans (MD); On-site; USD 40,000 - 55,000; Full time

Job summary

A leading company seeks a Manufacturing Associate I to support production areas by operating equipment, documenting cGMP activities, and maintaining manufacturing processes. The ideal candidate should have relevant educational qualifications and experience in a biotech or pharmaceutical environment, demonstrating teamwork and effective communication skills.

Qualifications

• High School Diploma plus years GMP experience or Degree in scientific field.
• Knowledge of cGMP practices and safety procedures.
• Fluent in English with strong communication skills.

Responsibilities

• Perform processing steps and manufacturing support activities.
• Document cGMP data and follow standard operating procedures.
• Prepare solutions and operate bench-top equipment.

Skills

cGMP understanding

Documentation skills

Team-oriented

Communication

Education

High School Diploma

Associate’s Degree in scientific discipline

Bachelor’s Degree in scientific discipline

Tools

pH meters

Conductivity meters

Osmometers

Pumps

Tubing welders

Filter integrity testers

Job description

SHIFT - PM - AM (ROTATION) - ONSITE POSITION - DURATION - - MONTHS

The Manufacturing Associate I performs 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.

Lifting to lbs., unassisted, may be required at times.

Frequent standing and walking are required, as this role requires presence on the manufacturing floor.

Key Responsibilities include but are not limited to:

• Performs processing steps and/or manufacturing support activities, monitoring processes against batch records.
• Documents/cGMP data and information for processing steps and/or equipment activities, following standard operating procedures. Key documentation includes batch records and equipment logbooks.
• Understands basic cGMP requirements and follows those requirements, including good documentation practices.
• Completes/reviews validation protocols, deviation reports, change controls in accordance with cGMPs.
• Performs weighing and dispensing of raw materials for media and buffers.
• Prepares small and large volume media and buffer solutions, performs filtration, and transfers product.
• Operates bench-top equipment including pH meters, conductivity meters, osmometers, pumps, tubing welders, and filter integrity testers.
• Handles dispensing, labeling, and transfer/staging of raw materials and parts.
• Assembles/disassembles, cleans, and sterilizes components, parts, and equipment.
• Maintains equipment, area, and cleaning logbooks.
• Performs cleaning and sanitizing of production rooms and equipment.
• Stocks production and cleaning supplies.
• May author/review/improve SOPs, batch records, protocols, and technical reports.
• Participates in training activities and manages their individual training plan.
• Proficient and knowledgeable in the operation and basic troubleshooting of at least one manufacturing area.
• Performs other duties as assigned.

Education & Experience:

• High School Diploma with a minimum of - years GMP manufacturing experience, OR
• Associate’s Degree in a scientific, engineering, or biotechnology discipline with a minimum of - 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 some relevant work experience.
• Basic knowledge of current Good Manufacturing Practices (cGMPs). Working knowledge of relevant safety procedures. General understanding of manufacturing and supporting functional groups.
• Experience with cGMP biotech or pharmaceutical operations is preferred.
• Must be team-oriented, proactively building healthy working relationships between peers, departments, and other groups.
• Fluent in English with excellent written and oral communication skills.
• Basic knowledge of non-manufacturing functions such as QC, Regulatory, QA, and Materials Management.

PHYSICAL DEMANDS:

• Extended periods of walking, standing, bending, reaching, pushing, and pulling.