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Manufacturing Specialist - Pharma Technology (OSD)

Job description

We are looking for a manufacturing specialist to join a leading pharmaceutical manufacturing company in Dublin as a Senior Pharmaceutical Technology Scientist (reporting to departments director). This role is responsible for the successful development, planning, execution, and support of project plans related to technology transfer and marketed product enhancement activities, ensuring site readiness at each project milestone.

This job works with various teams and site operations, facilities, laboratory, materials management and quality assurance personnel to coordinate Technical Services project activities with existing facility and production operations and ensures project activities are well coordinated, controlled, and executed as planned, in full compliance with all applicable standards, SOPs, Company guidelines, and regulatory agency codes and regulations.

You'd also be responsible for ensuring the Technical Services team provides high-level troubleshooting of existing and new processes, generates batch manufacturing records and standard operating procedures for all new technology, performs technical process investigations, and develops training methods for site personnel.

Salary - 50-55k + 15% Bonus + Medical + Pension

Contact

If you are interested in this job apply below. I also have more senior roles within QC, QA, QP, PV, RA, Validation, CQV, and other areas of pharmaceutical, medical device and biologics companies. Send me an email to schedule a confidential chat (014744692) - to "andrius at sigmar.ie" about roles or salary levels within the sector.

Job Responsibilities

  • Ensure process robustness by advocating for the inclusion into early stage product development of production concerns and recommendations so that the site is able to consistently supply the new product in the production environment in accordance with site strategic plan objectives.
  • Establish the expectation and standards, and the supportive environment, to ensure that project teams and support personnel have the capability to meet performance expectations. This includes building capability by providing ongoing coaching and mentoring and providing timely recognition as well as performance feedback and counseling.
  • Lead on-site new product development projects and ensure the successful execution of the Technical Services site project program.
  • Lead the preparation and execution of feasibility, NDA, pre-validation and validation protocols and reports that enable first time right execution of manufacturing processes.
  • Ensure the Technical Services team observes the Corporate Tech Transfer guideline and that the knowledge milestones are executed and documented thoroughly.
  • Maintain accountability for project team’s performance metrics that support the annual operating plan and site strategic plan objectives.
  • Manage the repository of Technical Services records and ensure they are in line with the registered critical process parameters detailed in the NDA for each product.
  • Ensure that all production batch procedural documentation, such as project change controls, change notices, risk assessment reports, process validation protocols and reports, new batch manufacturing records, and SAP BOMs, recipes and PI sheets, are current, accurate, and clearly define process and role responsibilities and that they are in place prior to the technical transfer of the process to manufacturing. Ensure records are updated as necessary post-transfer.
  • Ensure data reports on own team’s performance are current, accurate, and distributed according to defined procedures.
  • Lead the development of new Standard Operating Procedures for new technology and the continual improvement of the GMP procedural documentation (BMR’s, SAP PI Sheet, SOP’s, Forms).
  • Lead the on-going technical analysis and support of newly transferred and existing products, including process optimisation, lifecycle management, batch scaling and timely troubleshooting, performing root cause analyses and recommending preventative actions
  • Serve as subject matter expert (SME) on the site’s products, representing the site to internal and external (FDA) stakeholders.
  • Serve as lead on the Technical Services team to provide technical support during the implementation of new process technologies, including Qualification, FAT, IQ, OQ, and that they coordinate PQ and process validation.
  • Ensure site personnel are educated and trained on new technologies being introduced as part of the NPI program and on new and existing process technology or procedural changes.
  • Support and adhere to established processes and productivity targets.
  • Observe established escalation process for issues impacting established production-related Service Level Agreements (SLAs) and/or fulfillment of production goals.
  • Recognize and report to immediate supervisor any issues or deviations from accepted standards.
  • Provide status updates on own activities and productivity challenges according to defined procedures.
  • Seek process innovation and continuous process improvement.
  • Complete and conform to all training requirements for job role, including company-required and job role-specific training.
  • Carry out and assist in the on-going training of new and existing department personnel, as appropriate.
  • Observe all safety and compliance procedures and actively highlight any safety concerns to help drive the reduction of accidents or near misses

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