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Technical Manufacturing Operator

Walkersville, MD

Posted: 02/15/2021 Job Number: JN -022021-12531

Job Description

Technical Manufacturing Operator

SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.

Environment: A global leader and trusted supplier in the pharma, biotech and specialty ingredients markets. Headquartered in Basel, Switzerland, the company is focused on advanced manufacturing, high-quality control systems, regulatory expertise, and research and development (R&D) capabilities. The company s products and services include active pharmaceutical ingredients (API), stem cell therapies, drinking water sanitizers, vitamin B compounds, organic personal care ingredients, industrial preservatives and microbial control solution to combat viruses, bacteria and other dangerous pathogens.

Job Scope:
Title: Technical Manufacturing Operator
Location: Walkersville, MD
Industry: Pharmaceutical
Hours: M-F, 7:00am 3:30pm
Salary: Up to $24hr based on Experience paid weekly (Benefits Available)
Employment Type: Long Term Contract (Possible Extension)

Position Summary:
The Manufacturing Associate is responsible for the manufacture of therapeutic proteins (API) under cGMP conditions. Level I associates are expected to execute process recipes, follow written procedures (SOPs), monitor equipment and processes, perform basic laboratory tasks, including pH, conductivity, sampling, and conduct routine sanitization tasks to maintain facility and equipment. They are expected to attain a basic understanding of cGMP compliance while training under close supervision, demonstrating aseptic technique in handling of products and materials

Job Responsibilities:
Fill/Finish:
Responsible for executing aseptic processing in a clean room environment adhering to Standard Operating Procedures.
Complete documentation concurrently with completion of manufacturing processes.
Responsible for performing personal and environmental monitoring.
Be able to gown aseptically and work in an aseptic environment.
Process production batches in a LFBSC.
Responsible for filling vials ranging from .2mL to 60ml.
Responsible for filling bottles ranging from 100 mL to 1L.
Responsible for filling sterile bags ranging from 250mL to 20L.
Responsible for final product packaging of bottles, bags, vials (boxing).
Responsible for completing assigned tasks (for example, cleaning, lab setup etc.) related to departmental functions.
Perform preventative maintenance and general upkeep on equipment and facilities including environmental monitoring.
Responsible for reviewing SOPs, MBRs and other associated forms for revision; Revise SOPs, Batch Records or other documentation as needed.
Review and sign manufacturing batch records.
Assist in training entry level staff members.
Being available for business necessitated overtime is required.
Perform other duties as assigned.
*This position primarily encompasses with the various roles (Vialer, assistant, perform environmental monitoring) in the cleanroom to fill bulk media into bottles, bags, vials; Most employees spend the majority of their day in a cleanroom environment*.
Must be able to lift 50 pounds repeatedly and stand for long periods of time.
EOE/ADA

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