Pharmaceutical Operator

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We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.

This position is responsible for operating large scale manufacturing equipment to produce bulk APIs (Active Pharmaceutical Ingredients) in accordance with Company standards and operating procedures. He/she will be responsible for reports and documentation. Must be able to pay attention to detail due to the nature of chemicals and environment he/she will be working in on a daily basis.

• Operates in a regulated environment and complies with all cGMP and OSHA regulations applicable to manufacturing responsibilities. This includes understanding and following all applicable batch records, standard operating procedures and work instructions, and wearing appropriate personal protective equipment (PPE)
• Operates and monitors reaction vessels, crystallizers, centrifuges, filters, evaporator, heat exchangers, pumps, valves and other equipment through manual operations, panel boards, indicators, and HMI displays (for PLC and DCS controls) following applicable batch records, procedures, and good documentation practices.
• Operates and monitors hoists, dryers, mills, sifters, dust collectors, blowers, packaging stations, and other equipment through manual operations, panel boards, indicators, and HMI displays (for PLC controls) following applicable batch records, procedures, and good documentation practices.
• Packages, weighs, samples, and labels finished goods and intermediate products following applicable batch records, procedures, and good documentation practices.
• Maintains detailed operating reports and batch records, including notes on problems and records on added weights, volumes, measured temperatures, pH levels, pressures, and flow rates following applicable procedures and as directed by supervisor.
• Operates forklifts, hoists, and other material handling devices to move bulk raw materials, WIP, and packaged goods to and from pick-up points.
• Delivers samples to laboratory and retrieves operating supplies from storerooms.
• Monitors environmental and safety devices (scrubber, rupture discs, relief valves, etc.) to ensure that the equipment is functioning properly.
• Cleans and maintains work area, process equipment, tools and safety supplies according to regulatory and Company standards and operating procedures.
• Participates in various employee involvement teams and committees, such as Area/Site Safety Teams, Kaizen events, and Cost Savings Teams, to improve the workplace, increase efficiency, and maximize productivity.
• Performs Lock Out/Tag Out (LOTO) independently using personal lock.
• Other duties as assigned by Management.

• Has a basic understanding of equipment and processes in their area of responsibility.
• Can perform basic troubleshooting of equipment or process malfunctions in their area of responsibility.
• Exercises judgment within defined procedures and practices to determine appropriate actions.

• Works toward qualification in either all APAP Wet End operations or all APAP Drying Tower operations.

• No direct responsibility for the work of others
• Normally receives general instructions on routine work and detailed instructions on new assignments.

Education:

High School Diploma, GED, or equivalent required

Previous GMP Manufacturing Experience Preferred

Previous Experience In a GMP Manufacturing Environment (preferred)

• Must be able to communicate effectively in both verbal and written formats.
• Must be able to read and follow detailed instructions and procedures.
• Must be able to perform basic math.
• Must have a working knowledge of chemical and/or powder processing equipment and associated safety requirements.
• Must possess sound problem solving and decision-making skills.
• Must work in a team environment to perform job tasks and cover workstations during breaks and lunches.

• Reports to APAP Shift Supervisor in the APAP production department
• No positions report directly to the APAP Pharmaceutical Operator I
• Has frequent contact with: APAP production personnel, Quality (QA/QC), Safety and Maintenance

• Must be able to wear required Personal Protective Equipment (PPE), including hard hat, safety glasses, ear plugs, steel-toe boots, gloves, chemical resistant aprons and suits, and other personal protective equipment deemed necessary.
• Must be able to lift and carry up to 50 pounds. Material…