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IG Filling Shift Lead Technician - Weekend

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmic.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.

Description:

The IG Filling department has responsibilities for the setup (cleaning and sterilization) of components and vessels as well as the entire vial filling process (vial washing, depyrogenation, and filing within an isolator). As the department is responsible for the sterile preparation of components as well as the final filtration and filling of the product, attention to detail and compliance to procedures is critical to ensure the manufacture of a sterile product for our patients.

Each shift will be comprised of 6-12 manufacturing technicians that will have responsibilities on the setup and filling unit operations. In the Shift Lead Manufacturing Technician Role, the incumbent will have the following responsibilities:

  • With the support of the manager, lead the team during the shift in the absence of the shift supervisor, including understanding daily production schedule, assigning team members to tasks to accomplish production schedule, ensure pass down to next shift is completed, communicate / escalate issues to manager, and other tasks to ensure the success of the shift.
  • Lead the shift change meeting to assist the supervisor in collecting relevant process data, communicating schedule, organizing shift (responsibilities, breaks, etc.), directing team members, and communication of changes / issues.
  • Throughout the shift, monitor the execution of production tasks to ensure all EHS guidelines and policies are followed, procedures (job aids/SOPs) are being compliantly adhered to, the production schedule is met and delays are minimized. Escalate to supervisor as needed.
  • As required and with the support of supervisor and/or production engineer, be the manufacturing liaison with EHS, engineering, validation, and maintenance to ensure proper communication, equipment turnover, support, and equipment return to service activities are completed and documented to meet the production and maintenance schedule.
  • Become fully trained as an SME in all manufacturing operations to provide hands-on execution to support the team as well as first line of troubleshooting as issues arise.
  • Have accountability for all sampling requirements (COP, CIP, filled vial, isolator environmental monitoring) and transfer to Quality Control (QC)
  • Independently operate automation systems (EBM, DeltaV, PLC) at supervisor level, including creating EBM WOs, having understanding to amend or force tags or syncs, complete manufacturing review of alerts, fully understand equipment dashboard.
  • Lead the training of new employees to ensure they are able to quickly contribute to the team in a safe, compliant manner. This requires on the job training, mentoring of employees, and monitoring of their training status. Provide feedback on new employee training to the supervisor. Ensure all self-training requirements are met.
  • Create a continuous improvement mindset on the shop floor. Constantly work with the team members to develop and communicate process improvement ideas. Lead / support the implementation of process improvement ideas (5S, materials, job aids, tools, etc.) to support the team.
  • Be proactive (work orders, equipment preparation, materials, communication, etc.) to ensure the team does not encounter avoidable roadblocks during the shift.
  • Create new or update existing job aids based on process improvements or corrective actions to events. Lead document update through manufacturing management and quality assurance approval and submittal to the document control system.
  • Perform technician duties as needed to complete daily tasks.
  • Assist manager in developing and mentoring junior technicians.
  • Represent the dept. in cross functional teams as necessary.
  • May perform other duties as assigned

Requirements:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

  • Thorough knowledge aseptic manufacturing processes and equipment including but not limited to: COP washers, autoclaves, process tanks, CIP/SIP systems, isolators, and vial filling lines.
  • Knowledge of cGMP manufacturing and in-depth process knowledge of related manufacturing techniques/specialties.
  • Must be able to apply quantitative analysis to analyze process performance.
  • Incumbent must be proficient in a variety of mathematical disciplines and be able to work with both the metric and USA standards of measurement.
  • Must be able to read and follow detailed written instructions and have good verbal/written communication skills. Good procedural writing skills.
  • Knowledge of chemical and biological safety procedures.
  • Good computer skills, knowledge of Microsoft Word and Excel.
  • Must have demonstrated interpersonal and leadership skills and be able to lead a work team effectively and efficiently in a team environment.
  • This position requires shift, weekend and holiday work. Overtime may be required at times.
  • The incumbent must work in a clean room environment wearing special garments. Additionally, personal protective equipment must be worn due to safety requirements.
  • May require immunization before performing work within the manufacturing area.

Qualifications:

Experience in a regulated production environment is desirable:

  • Bachelors Degree in science / engineering with 1+ years of experience
  • AA or equivalent with 6+ years of experience
  • High School Diploma with 8+ years of experience


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