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Description

Pay XXX

Summary

Operates equipment used to manufacture products. Weighs, measures and checks raw materials to ensure that batches manufactured contain proper ingredients in proper quantities. (Serves as SME) Acts as a SME (technical expertise) and demonstrates mastery of tasks and processes in manufacturing drug product injectables in a cleanroom environment and following GMP standards. Conduct quality investigations and support process optimizations. Autonomously run equipment, pumps, and automated systems and train team members to ensure it's right the first time and on schedule. Push fluids through filters in chromatography columns. Set flow paths for the operations, following SOPs and Batch records and recommending improvements.

Responsibilities

• Acts as a high-level technician on the floor providing guidance to other technicians and driving daily operations. Provide critical evaluation of processes, including foresight and thinking ahead. Act as a guide to new employees during onboarding process. Has substantial understanding of the job and applies knowledge and skills to complete a wide range of tasks.
• High Level Skilled: Aseptic Gowning / material flow, Applicable processing equipment, SAP/BLV. Works on assignments that are moderately difficult, requiring judgment in resolving issues or in making recommendations.
• High impact to work. Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines. Maintains the necessary compliance status required by company and facility standards.
• Stays up to date on required job training. Maintains up to date training records. Qualified trainer on a complex equipment/processes.
• SME or Expert on 1 Unit Operation. Obtains samples of batches/products in accordance with company procedures; submits samples to required functional areas for testing and to determine specific properties. Records/analyzes results and takes appropriate action.
• Responsible for the upkeep of manufacturing equipment. Recognizes equipment and product problems, notifies supervisor and/or troubleshoots errors in order to achieve optimum production levels.
• Review, revise, & author manufacturing batch records. Collaborate with Quality & PD to review & signoff on executed batch records. Own the batch record reconciliation. Review, revise, & Author WIs/SOPs.
• Adhere to the Quality Management Systems by living the Quality values every day and holds peers across the site accountable as well. Assist with the on-time closure of Nonconformance s/ CAPAs
• Lead PPI initiatives and continuous improvements.
• Identify and communicate items requiring escalation; execute post escalation decisions. Provide frequent feedback and coaching to others on ways to improve performance. Receives and checks raw materials and formulation deliveries and completes appropriate records in accordance with company procedures (MFP s/EOP s/LOP s/SOP s).
• Active participant of performance huddles and assist supervisors to plan out and populate process schedules.
• Maintain a culture of safety by identification of near misses, safety walkthroughs and assisting with resolution of safety observations. Ensure chemicals are properly stored and labeled.
• 90% of time spent on the floor
  

Work Hours:

• This position will generally require the ability to work a 12-hour rotating shift in a 24-hour, 7 day per week operation to include evenings and holidays.
• 7pm-7am
  

Education/Experience/Equivalency:

• High School Diploma / 3+ years of relevant experience or superior demonstration of skill sets or background
• Bachelor s Degree in related field / 1+ years of relevant experience or superior demonstration of skill sets or background.

Knowledge, skills and Abilities:

Full GMP understanding. Demonstrated ability to lead and mentor. Understanding of the science behind the process with ability interpret data and inputs. Strong communication skills (verbal and written). Good autonomous problem-solving skills. Investigative skills. Understand cleanroom concepts. Ability to follow directions & procedures and work in team environment. Strong attention to detail and drive to accomplish the job timely, accurately and safely the first time is required, as well as the ability to work closely and effectively in a team environment. This position will generally require the ability to work a 12-hour rotating shift in a 24-hour, 7 day per week operation to include evenings and holidays. Ability to apply knowledge of Good Manufacturing processes and the knowledge and skills in pharmaceutical processes, equipment, instrumentation, and procedures. Adhere to all Personal Protective Equipment (PPE) requirements used within cGMP manufacturing.

Physical Requirements:

Employee is regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; sit and to talk or hear. The employee is required to walk and stoop, or kneel, crouch approximately 80% of the time. The employee is required to ascend/ descend stairs approximately 20% of the time, lift a maximum of 50 lbs., and sit for a maximum of 4 hours. Specific vision abilities required by this job include close vision and ability to adjust focus with tasks.