Work Schedule
12 hr shift/nights
Environmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, Loud Noises (Equipment/Machinery), Office, Rapid flashing lights, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials, Working at heights
Job Description
Location/Division Specific Information:
Greenville, NC/DPD
What will you do?
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Operate lyophilization equipment to manufacture products strictly adhering to specifications.
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Ensure the accuracy and currency of batch records and data sheets for batches currently being processed.
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Monitor environmental conditions to ensure sterility standards are met, advancing any issues promptly.
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Perform preventative maintenance tasks to ensure equipment and areas meet specifications.
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Identify and troubleshoot equipment and product/process issues, notifying supervisors to maintain optimum production levels.
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Confirm and record production activities in batch records and logbooks.
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Assist in troubleshooting operational and production problems, determining appropriate corrective actions.
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Perform visual inspection and turnaround activities for freeze-drying equipment and prepare equipment and components for operations.
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Assist in commissioning new equipment and production areas, as well as initial and subsequent validation of equipment and processes.
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Maintain and clean classified environments/areas.
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Communicate effectively to resolve production, quality, or safety issues.
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Align with all job-related safety, cGMP, and other department procedural requirements.
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Participate in On the Job (OJT) training programs, area safety initiatives, and area initiatives.
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Train new employees.
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Perform other duties as assigned.
How will you get here?
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The minimum requirement is a high school diploma or equivalent experience, with a preference for a technical degree.
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1 year of regulated manufacturing (Pharmaceutical preferred), mechanical, or similar experience is preferred but not required.
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Equivalent combinations of education, training, and relevant work experience may be considered.
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General knowledge of mechanical, electrical/electronic, pneumatic, and hydraulic pharmaceutical industry equipment.
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Effective verbal and written communication skills.
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Basic computer skills.
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Strong interpersonal skills.
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Ability to work independently.
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Flexibility with departmental work schedules, including overtime and all shift operations.
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Ability to achieve and maintain qualifications to work in a cleanroom environment.
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Capability to stand, walk, bend, kneel, and crouch intermittently for extended durations.
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Ability to lift, carry, and move medium weights of 25-50 pounds; occasionally push and pull 50-100+ pounds.
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Strong eyesight to operate a keyboard, computer screen, machinery, and read documents for extended durations.
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Full range of motion in upper and lower extremities.