Pharmaceutical Technology Specialist III

HERO

Job Detail

Location Dublin
Salary Negotiable
Posted
Role Type Fixed Term Contract
Contact Marc Glennon
email contracting@hero.ie

Pharmaceutical Technology Specialist III

Apply Now

Job ID: JOB-11980

Pharmaceutical Technology Specialist III

My client is looking to recruit a Pharmaceutical Technology Specialist III to join their diverse Global Pharma Technology team in Dublin. The Pharmaceutical Technology Specialist III is responsible for coordinating and executing technology transfer and marketed product enhancement activities. The position incumbent serves as site lead on technology transfer teams. The Pharmaceutical Technology Specialist III 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.

The Pharmaceutical Technology Specialist III adheres to all applicable laws and regulations as well as internal Company policies and procedures in the performance of the job role and applies skills and knowledge to recognize and resolve issues that impact efficiency, throughput, quality, and/or the fulfillment of the assigned performance targets. The Pharmaceutical Technology Specialist III is responsible for the safe, compliant, and efficient execution of job duties in a team environment. This position reports to the Director Pharmaceutical Technology

Key Responsibilities:

  •  Other duties may be assigned. Serve as site representative on technical transfer project teams, ensuring that production concerns and recommendations are factored into early stage product development in order to optimize manufacturing processes and ensure the site’s ability to consistently supply the new product in the production environment.
  • Lead on-site new product development projects to meet the facility strategic objectives, including coordinating project activities across all relevant functions and internal and external resources and monitoring and reporting project status.
  • Execute the validation strategy for each new product being transferred or existing product being enhanced, including providing recommendations for batch sizes against forecast and performing and maintaining risk assessments.
  • Prepare and execute feasibility, NDA, pre-validation and validation protocols and reports that enable first time right execution of manufacturing process.
  • Follow the Corporate Tech Transfer guideline and ensure that the knowledge milestones are executed and documented thoroughly.
  • Maintain records in line with the registered critical process parameters detailed in the NDA for each product.
  • Manage the generation of 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, and ensure all relevant documents are current, accurate, and clearly define process and role responsibilities prior to the technical transfer of the process to manufacturing.
  • Update records as necessary post-transfer.
  • Develop new Standard Operating Procedures for new technology and make recommendations for continual improvement of the GMP procedural documentation (BMR’s, SAP PI Sheet, SOP’s, Forms).
  • Provide on-going technical analysis and support on newly transferred and existing products, including process optimisation, lifecycle management, batch scaling and timely troubleshooting, performing root cause analyses and recommending preventative actions.
  • Provide technical support during the implementation of new process technologies, including Qualification, FAT, IQ, OQ, and coordinate PQ and process validation.
  • Educate site personnel on new technologies being introduced as part of the NPI program and develop training materials and programs for 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 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.

ADDITIONAL JOB RESPONSIBILITIES:

  • May lead department initiatives and projects
  • A third level qualification in Chemistry or related Science, preferably a Bachelor’s Degree
  • Experience: 2 years related experience and/or training; or equivalent combination of education and experience.
  • Experience in pharmaceutical manufacturing facility.
  • Experience working with pharmaceutical processing technologies and good understanding of 21CFR / cGMP documentation and electronic systems requirements.
  • Demonstrated experience applying sound and critical reasoning to troubleshoot complex process challenges.
  • Demonstrated success in making effective and persuasive presentations on complex topics to upper management.

Knowledge and Skills:

  • Proficiency of computer skills with Microsoft Word, Excel, Outlook.
  • Technical expertise in the pharmaceutical technology and automated control systems
  • Demonstrated Behaviours: Exhibits a high personal drive for excellence and holds self accountable for consistently high quality performance results.
  • Understands the vision, strategy, and goals of one’s own function and of the site, and adeptly evaluates, plans, and prioritises own work accordingly, creating efficient workflows to manage multiple activities and using time and resources effectively to deliver expected results on or before deadline.
  • Demonstrates a commitment to innovation and continuous improvement by engaging in an ongoing assessment of processes and generating ideas and recommendations for increasing quality and efficiency.
  • Demonstrates ability to perform effectively under pressure and challenging conditions, maintaining focus and intensity and remaining optimistic and persistent while working to achieve expected results.
  • Models open communication and information-sharing, consistently keeping all stakeholders informed of own deliverables.
  • Demonstrates ability to collaborate within own and across other functional and organizational boundaries and use influence positively and skillfully to find common ground in order to achieve goals.
  • Uses experience, technical expertise, and established standards and methods to analyze and solve problems and exercises sound judgment about when to take action and when to escalate issues to the next level of expertise.
  • Demonstrates an ability to make logical, well-informed and timely decisions within scope of job role authority and take timely action to achieve goals.
  • Understands and supports the need for change and demonstrates flexibility and openness to changing conditions.
  • Demonstrates the desire and ability to grow own capabilities by seeking out and engaging in challenging learning opportunities that enhance contribution to site and advance professional and career development.
  • Demonstrates a personal commitment to site safety by actively fostering a safety culture and upholding all safety standards in the performance of job duties. .

KEY PERFORMANCE METRICS:

  • Right first time process validation on new products and equipment performance qualifications
  • Schedule adherence on NPI and lifecycle management projects

Marc Glennon

JOB-11980

Apply Now

Pharmaceutical Technology Specialist III

Marc Glennon

Role Type Fixed Term Contract
Contact Marc Glennon
email contracting@hero.ie
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