MF EM Operator I (1st shift)

Core Hours: Monday - Friday 6:00am - 2:30pm

Purpose and Scope

The MF EM Operator I performs routine activities related to supporting the injectable team, while ensuring that products are made with quality for our patients.

Key Responsibilities

• Perform job responsibilities in accordance with standard operating procedures (SOPs) and production records with an expectation of "Right the First Time".
• Perform job in a clean room environment requiring clean room gowning, including but not limited to:
• Company-provided Scrubs
• Shoe Covers and Sterile Boot Covers
• Hairnets (and beard covers as applicable)
• Tyvek Coveralls
• Gloves
• Full-face masks/hoods
• Goggles
• Chemical Protection PPE
• Assist in setup and manufacture (bulk, fill, stopper, label, and package) clinical supplies and commercial pharmaceutical products in an aseptic environment in accordance with production batch records.
• Assist in the set-up and operation of semi-automatic filling equipment used to fill syringes for injectable products in both general manufacturing and sterile manufacturing areas.
• Perform routine sampling and inspections of pre-filled syringes for injectable products.
• Assist in the set-up and operation of compounding equipment used to produce bulk material for injectable products.
• Perform biological sampling of general manufacturing clean room facilities.
• Assist in set-up and operation of semi-automatic packaging equipment used to package pre-filled syringes.
• Document production activities using regulatory controlled documents including production records and log books.
• Perform facility cleaning of manufacturing areas as required to maintain a cGMP environment and by TOLMAR Standard Operating Procedures.
• Perform visual and physical inspections of in-process and finished product as requested.
• Responsible for assembly, disassembly and sanitation of various equipment.
• Perform job duties with a second checker present.
• Responsible for quality of product.
• Train other Aseptic Operators in the Injectable Products team to perform job duties related to their position.
• Handle hazardous raw materials and cleaning solutions following all applicable safety procedures and policies.
• Formulate bulk materials.
• Maintain proper use of aseptic techniques.
• Operate under the direct supervision of a Lead Operator and/or Supervisor.
• Perform environmental monitoring in the general and aseptic manufacturing environment.
• Perform Aseptic gowning qualifications and participate in aseptic process simulations.
• Incubate and enumerate organisms on cultured media.
• Participate in required annual hazardous waste training. Hazardous waste involvement may include, but is not limited to container and tank management and inspections, generation of hazardous waste as a part of production or sampling processes and transfer of hazardous waste between lab procedure area, satellite accumulation and storage. Respond to spills per the Chemical Spill Procedures.
• Perform other duties as assigned.

Special Skills and Knowledge

• Working knowledge of current Good Manufacturing Procedures (cGMP).
• Ability to stand for extended periods of time (up to 8 hours or more).
• Working knowledge of computer software.
• Ability to maintain focus on detail-oriented, repetitive tasks.
• Good verbal and written communication skills.
• Ability to follow and understand written production records and validation protocols.
• Strong math and writing skills to document production activities in batch records and/or log books.
• Attention to detail for documentation in production documents and to compare produced goods against specified requirements.
• Capability to operate on a fast-paced manual assembly line using basic production equipment.
• Ability to legibly complete required documentation.

Core Values

• The Manufacturing EM Operator I is expected to operate within the framework of Tolmar's Core Values:
• Consistently operate with the highest standards of ethics and compliance.
• Take ownership of your actions, success and setbacks.
• Respect each other and understand that honest collaboration is at the heart of our company success.
• Go the extra mile to make things happen.
• Be committed to all we do and the patients we serve.
• Embrace change with enthusiasm.
• Strive to learn about and understand the needs of customers and patients, and take action with great speed and efficiency no matter the task.

Communication

• Interact with peers and members of other departments in team settings in a professional manner.

Education & Experience

• High school diploma or equivalent required.
• 1 or more years of experience in a GMP manufacturing environment.

Additional Requirements

• Acceptable results on both a quantitative and verbal assessment test.
• Valid driver's license and acceptable motor vehicle record may be required.
• Shift work in a manufacturing and warehouse environment.
• May require overtime.
• Passing results on an internal inspection qualification for syringe inspection on semi-automated equipment for one syringe type.

Compensation and Benefits

• Pay: $23.33 per hour
• Benefits summary:

Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.

Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.