Sets-up, operates, and maintains the classified environments and manufacturing equipment for pharmaceutical products. Requires proficiency in: cleaning and sterilizing equipment, gowning and aseptic techniques, preparing equipment and components for operations, operating and troubleshooting mechanical equipment, following approved procedures and proper documentation. Functions as Subject Matter Expert (SME) for areas of expertise.
Ensures operations are performed in a safe and responsible manner striving to create an injury-free and incident-free workplace.
Ensures pharmaceutical products in manufacturing are in accordance to Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMPs) and other batch related activities. Verifies and documents production activities in batch records, logbooks, etc.
Sets-up and troubleshoots complex and critical mechanical equipment, operational and production problems in order to identify appropriate corrective actions.
Performs the disassembly, assembly, cleaning, and operation of area manufacturing equipment. Prepares equipment and components for operations. Possesses general mechanical, electrical/electronic, pneumatic, and hydraulic knowledge of pharmaceutical industry equipment.
Assists in the commissioning of new equipment and production areas. Assists in initial and subsequent validation of equipment and processes.
Communicates and works to resolve any production, quality or safety issues.
Assists Supervisor and Production Lead in coordinating and motivating department employees to ensure finished product is in accordance to cGMP requirements, gathers information to accurately identify the root cause of problems in equipment or work processes, fosters crew teamwork in such a way that promotes increasing employee knowledge, and assists with data entry into SAP system.
Complies with all job-related safety, cGMP, and other department procedural requirements.
Trains new employees. Supports the on the job training (OJT) program, area safety initiatives, and area lean manufacturing initiatives.
Performs other duties as assigned.
High school diploma or equivalency is required.
Minimum two years of relevant work experience in the pharmaceutical industry.
Equivalent combinations of education, training, and relevant work experience may be considered.
Effective verbal and written communication skills. Basic computer skills. Strong interpersonal skills. Ability to work independently. Flexibility with departmental work schedules, including overtime and all shift operations. Ability to achieve and maintain qualifications to work in a cleanroom environment. Ability to drive a fork lift and other mobile equipment to locate product and equipment as needed.
Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of medium weights of 25-50 pounds; occasionally pushing and pulling 50-100+ pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Ability to climb stairs and ladders. Full range of motion in upper and lower extermities.
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