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• Prepare a variety of media and stock solutions that are transferred from tank to bag or tank to tank in order to support cell culture main operations to facilitate proper cellular growth per SOP.
• Able to follow SOP’s to perform routine cleaning activities of parts and equipment using manual cleaning methods, designated parts washers, Clean-In-Place (CIP) and COP(Clean-Out-Of-Place) systems. As well as collecting rinse water samples and performing swabs on required equipment for testing.
• Execute proper documentation and measures to initiate changing over of parts and equipment to be released for use.
• Produce pre-assembled weighing kits which consist of raw materials weighed out, bagged, and labeled that are used down the process per SOP.
• Performs a majority of operations in a cGMP clean room environment.
• Practices ergonomic safety and use appropriate personal protective equipment (PPE) in all operations.
• Documents execution of operations through the Bio Manufacturing Execution System (BioMES), batch record and equipment use logbook using Good Documentation Practices (GDP). Interchanging between electronic and paper documentation procedures.
• Performs internal support duties including stocking consumables/materials, updating controlled SOP binders, appropriately discarding expired reagents, recognizing and reporting process and equipment anomalies.
• Reports any issues related to manufacturing performance, process and safety to the team lead or Manager in order to ensure safety and compliance with regulations and cGMPs and to facilitate continuous process improvement.
• Participates in training and development opportunities in order to gain an understanding of SOPs, GMPs, regulatory compliance requirements and departmental policies.
• Performs routine housekeeping of the manufacturing plant using the 5S organization methodology by using appropriate equipment safety signage, labeling of parts-in-process, sweeping water pools to the floor drain, and picking up parts from the floor.
• Collaborates within team and department in order to follow best practices and meet department goals.
• Demonstrated ability to be organized and work well in small work groups.
• Must be able to assist in trouble shooting activities and repairs to production equipment under the guidance of more experienced technicians.
• Demonstrated mathematical skills, including the ability to perform addition, subtraction, multiplication, division, and conversions.
• Detail oriented. Demonstrated ability to read, comprehend, and follow written instructions.
• Demonstrated written and verbal communication skills are required.
• Must be able to work in a team environment.
• Experiences in related biotechnology/pharmaceutical industry strongly preferred
• Must be able to learn and perform basic computer operations such as MS Office and Outlook and other computer based software
• Preferred skills include experience in: Current Good Manufacturing Practices, Mammalian cell culture, Bio Manufacturing Execution System (BioMES), Process Control System DeltaV, Laboratory Management Information System (LIMS)
• Physical Demands / Surroundings- Requires physical activity such as almost constant standing, walking, eyestrain, etc. Must be able to occasionally lift up to 25 lbs. Works regularly under desirable conditions with some moderately disagreeable conditions in the manufacturing setting.
• Visual Demands - Position requires constant use of computer terminals and routine / repetitive work.
• Temperaments/Mental Requirements- The position requires concentration as errors might cause minor to moderate delays, confusion, or expense to correct. The position has some contact with other departments and the associate must be able to discuss issues and ideas with an open mind and even temper.
• Level of Proficiency - Entry level in subject matter
• Attendance / Schedule-The schedule is dependent on the shift for which the associate is hired. Attendance requirements are based on general attendance policies.
• To remain in this position, employees:
• Must obtain & maintain qualifications, as required, to perform the assigned work.
• Must understand, will be held accountable for and must adhere to all SOPs, company Policies and Procedures
• Must adhere to proper technique, proper documentation practices, and all other aspects of the cGMP’s
• Must maintain all training requirements and regularly checks the LOS training system in order to complete all required training on time.
Requires a High School Diploma or equivalent plus four
(4) years closely related technical experience, preferably in a
pharmaceutical or chemicals manufacturing environment. An Associates
Degree with a minimum of two (2) years closely related technical
experience, preferably in a pharmaceutical or chemicals manufacturing
environment; or a Bachelors’ degree, preferably in a science or
engineering field is preferred with 1+ years of GMP exp.