Operations Technical Support Specialist (S3)

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  • Full Time
  • Dublin

CPL

About the job

Operations Technical Support Specialist (S3):

General Information:

Job Title: Operations Technical Support Specialist

Department: Operations Technical Support

Position Reports to: Operations Technical Support Lead

Job Responsibilities:

  • Be recognised as Process Subject Matter Expert which will be supported through dedicated training and development opportunities.
  • Strong experience in Parenteral /Aseptic Manufacturing process.
  • Development and execution of Continuous Improvement (CI) projects which will be supported with Lean Six Sigma Training and certification.
  • Support CI process by attending CI meetings and leading CI as required.
  • Provide day to day technical support to the parenteral manufacturing unit in addition to exposure to network based initiatives.
  • Lead Audit Preparation and audit support for your area.
  • Provide day to day operations and compliance support.
  • Be proactive in error proofing and aiming to prevent human errors and events.
  • Support the operating unit in preventing investigations to enable timely disposition.
  • Provide operations support for projects in your area of expertise.
  • Own and lead investigations pertaining to your particular focus area.
  • Identify and implement SMART CAPA’S that error proof and drive down repeats and overall deviation reduction for the suite.
  • Identify, and implement improvements to, recurring process and procedural inefficiencies that do not necessitate event reports.
  • Technical input to developing and optimizing work processes (SOPs etc.) within your area of expertise. Lead revisions to these documents as required.
  • Act as the point of contact for introduction of procedure and document changes including: red-line procedures for improvement; review procedural revisions prior to implementation, prepare and deliver training for new documents and revision training and re-training.
  • Own operations commitments / change controls / interfacility and vendor complaints / action items within your area of expertise.
  • Support the Medical Device Combination Product (MDCP) CAPA process in Parenterals.
  • Proactive & effective communication within and across shifts.
  • Proactive engagement with key stakeholders at senior level within the business.
  • Engage with partners in based in other Pfizer sites to establish a technical forum of practice.
  • Demonstrate the Pfizer GC Culture and Values
  • Personal Development plans focus on the 70:20:10 guidelines
  • Adhere to all HR Policies as appropriate

Education/Experience

  • Third level Qualification in Science, Engineering or equivalent is preferred. Exceptions may be considered where relevant skills/experience and correct attitude and behaviors exist (this may be supplemented by further education in parallel).
  • Experience in a Biopharmaceutical or Pharmaceutical cGMP-manufacturing environment essential.
  • Experience in operating within a regulated environment (EMEA, FDA).
  • Ability to efficiently use current computer packages in particular Excel, PowerPoint, MS Project and Word.
  • Proven technical writing skills in the completion of complex investigations.
  • Demonstrated aptitude for technical learning and problem solving.
  • Proficient understanding of aseptic process manufacturing. Previous experience with formulation, aseptic filling and / or automated visual inspection highly desirable.
  • Experience in leading investigations to closure identifying true root cause and effective CAPA’s is preferred.
  • Previous experience with systems such as an electronic document management system (PDocs), QTS, SAP, MCS and MES highly desired.
  • Demonstrated ability to lead, influence, and train others.
  • Demonstrated ability to lead method 1’s and troubleshooting with a cross functional team.
  • Excellent interpersonal and communication skills.
  • An ability to deal with process change and implement new effective processes.
  • An ability to work through peers and across organizational boundaries and influence at all levels in the business.
  • An ability to think analytically and innovate to achieve goals.
  • This job description indicates the general nature and level of work expected of the incumbent. It is not designed to cover or contain a comprehensive listing of all activities, duties or responsibilities required of the incumbent. Incumbents may be asked to perform other duties as required.

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