Manufacturing Operator (Mixing/Batching - Pharmaceutical)

Job Description:

We are seeking Manufacturing Operators for our client in Wilmington, DE. The Manufacturing Operator is responsible for the batch-wise manufacture of active pharmaceutical ingredients in a safe and GMP compliant manner. The Manufacturing Operator carries out tasks associated with chemical manufacturing utilizing batch logs, standard operating procedures, and work instructions under cGMP guidelines. The Manufacturing Operator adheres to all safety, quality, and compliance regulations, procedures, and guidelines, with special care given to protect the environment in which we operate.

Responsibilities:

• Complies with company policies and procedures, established safety procedures, and maintains a safe and clean working environment.
• Oversees manufacturing process composed of steps such as set-up, loading, unloading, processing, drying, documentation, and follow-up.
• Accurately completes batch logs and other documentation to produce product efficiently and in compliance with cGMP and standard operating procedures.
• Proper operation of process controls, DCS systems, pneumatic, hydraulic and electrical equipment as detailed in procedures to product materials in a safe and cGMP environment.
• Recognizes and documents 'abnormal' operating conditions with proper response including immediate notification of supervision.
• Inspects components and products of the production cycle for compliance with applicable standards.
• Ability to use SAP to electronically document transactions.
• Inspects components of the production cycle for compliance with standards.
• Makes good use of hold periods for subsequent processing steps. Utilizes idle processing time to perform other production related activities (housekeeping, lean initiatives, training, etc.)
• Understand and participate in operator asset care initiatives.
• Other duties as assigned.
• Carries out duties in compliance with all state and federal regulations and guidelines including FDA, EPA, OSHA and DEA. Complies with all company and site policies and procedures. Recognizes and reports unsafe conditions and procedures to supervisors immediately with relevant documentation.
• Successfully completes regulatory and job training requirements on time.
• Participates on investigative teams and site group initiatives (PHAs, PSSR, etc.).
• Understands and responsibly performs duties with attention to safety, environmental matters, quality, compliance, and controlled substances handling. Items include; wearing appropriate personal protective equipment, recognizing, reporting and appropriately responding to hazards in the work area (spills, accidents, near misses, etc.), maintaining proper housekeeping at all times, properly labeling and storing chemicals, plus all other relevant job requirements.
• Assists in training operators.
• Makes positive contributions demonstrated by:
• Making suggestions for improvement and recommending solutions
• Providing overtime as needed
• Learning new skills and processes

Job Requirements:

• High school diploma or general education degree (GED).
• Work experience in a chemical and/or pharmaceutical environment.
• Two to four years related experience and/or training or equivalent combination of education and experience.
• Read, understand, and interpret documents such as safety procedures, batch logs, operating and maintenance instructions, government regulations and procedure manuals.
• Write routine reports, operating procedures, and correspondence with supervisory assistance if required.
• Add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
• Compute rate, ratio, and percent and be able to create and interpret bar graphs.
• Calculate figures and amounts such as proportions, percentages, area, and volume.
• Mechanical aptitude of production equipment and processes.
• Ability to safely operate a forklift.
• Use computer software applications including Microsoft Office suite.
• Work well with others in a team environment, influencing people in opinions and behaviors consistent with good leadership examples.
• Perform a variety of tasks, changing tasks frequently, staying focused, maintaining attention to detail, with a focus on Safe and Right First Time production
• While performing the duties of this job, the employee is regularly required to stand, walk, climb, band, and stoop. The employee uses hands to handle and feel and must reach with hands and arms.
• The employee frequently is required to talk, hear, taste, and smell.
• The employee must occasionally lift and/or move up to 50 pounds.
• The employee is frequently exposed to weather conditions including occasional extreme heat and cold.
• The employee must be able to qualify for and use respiratory protective equipment.
• Specific vision abilities required

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