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  • 3 weeks ago

jobs description

The closing deadline for applications is Friday, 8th March 2024.

Why Patients Need You

Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative engineering team, you'll help bring medicines to the world even faster by imagining what’s possible and taking action.

What You Will Achieve

Working with Pfizer’s dynamic engineering team, you will play a critical role in the design and development of manufacturing processes to bring products from research to manufacturing. You will leverage your technical capabilities to comprehend the inherent problems of transfer of technology from the research stage to manufacturing, in cooperation with pilot-plant and production departments. You will conduct tests and measurements throughout the stages of production and troubleshoot... production process problems with processes or equipment already in operation.

As a Manager, your planning skills will help in preparing forecasts for resource requirements, and providing areas of improvement for products, processes or services. Through your comprehensive knowledge of principles, concepts and theories of engineering, you will also work towards advancing new concepts and methodologies. You will be able to take a leadership role to facilitate agreements between different teams.

It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.

Parenterals Technical Services - Principal Scientist

Role Description

The Principal Scientist will provide process science and validation assistance for the manufacture of sterile drug products in the Parenterals Suite, as well to assist process technology transfer projects into site for any new products/processes that may arise. The Principal Scientist is accountable to ensure that the process is running as intended, and that it is appropriately validated.

The Principal Scientist will be the primary technical subject matter expert and provide leadership in drug product formulation, sterilization of drug products, aseptic filling into primary packaging components and the visual inspection process.

Duties include leading process investigations, implementation of cost reduction projects, facility and equipment improvements, assisting in technology transfer execution including process trials on the bench or at scale in support of these project objectives, and execution of final process and cleaning validation studies and write-ups. The role also provides validation and technical support to across the Pfizer network.

The Principal Scientist will establish strong network partnerships as required (with MSAT, Pharm Sci and Co-Dev Teams) to deliver integrated technology solutions to enable the site business objectives. The role may entail specialization and training in process science/engineering to meet overall site business needs for technical support e.g. process validation, technical risk evaluation, filtration, single-use technology, drug product formulation, syringe filling and inspection etc. In addition, the role may involve some travel to external donor sites to capture process knowledge or for support of technology transfer.

Responsibilities

Provides technical expertise for investigation and resolution of process deviations, root cause investigation, CAPAs, process improvements, and preparation of regulatory filings. Demonstrates a strong knowledge of cGMP compliance, site and regulatory agency requirements and procedures and participates in inspection readiness. Supports process technology transfer, process validation and the preparation of CMC documentation for regulatory filings for the Parenterals Facility. Provide oversight of the aseptic process simulation program and support the routine and ad-hoc media fills Provide in-depth process expertise to support Parenterals manufacturing including - process changes by Change Control, filtration trouble-shooting and resolution of aseptic manufacturing process and technology issues. Provide oversight of the Medical Device Combination Product (MDCP CAPA) process and performs Area Functional Manager duties Carry-out process transfers to site in-line with existing guidelines, network procedures and with industry best practices. Develop process validation protocols and lead their execution on the floor in conjugation with Operations. Write up process validation summary reports and associated filing summaries. Design and execute Filter Validation and Shipping Validation studies. Provide technical training on process and technology areas as required.

Qualifications and Experience

The successful candidate must possess a science or engineering degree in the biotechnology, biochemical, chemical or related disciplines, along with >10years experience in commercial aseptic manufacturing. A strong practical knowledge of the technologies related to sterile drug product manufacturing is essential. Effective resource planning and execution are essential, as well as highly effective leadership skills and capabilities are required for this position. Proven experience in successful execution and management of process technical transfer. Demonstrated aptitude for technical learning, problem solving, continuous improvements and data analytics. Excellent verbal & written communications skills. Interpersonal and facilitation skills necessary to interface with and influence all levels of the organization with the ability to lead people and multi-disciplinary teams Strong statistical background with experience working with Excel, Minitab, or Statistica. Knowledge of Quality requirements and FDA and EMA Regulatory guidelines.

Work Location Assignment: Flexible

Additional Information

In order to be considered for this position in Ireland you need to be legally eligible to work in Ireland.

Please note there is no relocation support available for this position





Purpose

Breakthroughs that change patients' lives ... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.

Digital Transformation Strategy

One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.

Equal Employment Opportunity

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.

Engineering
Dublin Ireland

salary-criteria

Apply - Principal Scientist Dublin