Process Scientist

Job Purpose
This role is to provide process science support to the ongoing requirements of the DSP (12K) Operating Unit. The Process Scientist should have specific SME knowledge in Upstream and Downstream biological processes or similar processes. As a Process Scientist you are responsible for providing support to the operating unit ensuring that the processes are robust and that all issues are resolved to support the manufacture and timely disposition of product.
This role focuses on leading and resolving technical issues within the Operations Unit, implementation of CAPAs and process improvements, investigation lead for process related issues and maintaining the qualification status of the physical plant and equipment.
The Process Scientist is responsible for project management and execution of assigned projects (short duration) and dealing with various on-site/off-site stakeholders as applicable.
Job Responsibilities:

• Lead investigations (deviations) to closure providing appropriate root cause analysis, product/process impact assessments and effective CAPA implementation in a timely manner
• Demonstrate SME process knowledge for Upstream / Downstream process steps
• Provide SME process technical support and troubleshooting for resolution of manufacturing issues
• Provide technical training on the process as required by Operations
• Follow up on process monitoring/robustness actions as required
• Lead/represent team on short duration project teams where responsibilities would include SME technical oversight and the management and resolution of technical issues or changes arising throughout the project lifecycle whilst ensuring overall project objectives of scope, cost and schedule are adhered to
• Liaising with stakeholders within the OpU/within Pfizer
• Support/Lead Continuous Improvement and Safety initiatives as required
• Develop and maintain productive links with Operations, MSAT, Quality Operations, Core Engineering and Core Technical Services
• Identify process (and equipment) improvements and develop these into project scopes which also may include progressing to funding approvals and presentation at OpU or site level

• Work to implement a culture of Right-First Time and Zero Defects through partnerships with Operations and Core Engineering and Core Technical Services
• Take part in Audits and provide input as an SME into Audit defence
• Productive collaboration with Engineering Operations and Process Engineering groups to implement and maintain effective CAPAs
• Support coaching of other colleagues on team

Education/Experience

• Third level Qualification in Science, Engineering or equivalent is preferred, exceptions may be considered where relevant skills/experience and correct attitude and behaviours exist (this may be supplemented by further education in parallel)
• Particular emphasis in Chemical or Biological sciences discipline

• 5+ years cGMP experience within Biopharmaceutical manufacturing or related areas required (Technical Operations/Services or Engineering)
• Experience working independently with eQMS (Veeva Vault/QTS) specifically change controls, commitments and investigation writing
• Method One certified
• Knowledge of upstream cell culture and downstream purification operations desirable
• Knowledge of mRNA manufacturing operations desirable
• SME understanding of the elements of upstream and downstream processing and how issues can impact product and continued production desirable
• Experience and working knowledge of Process Monitoring systems
• Experience working with automated control systems.
• Expertise in using MCS, PI, LIMS and AMPS with capability to query same in support of process understanding
• Excellent communication and interpersonal skills and an ability to work independently and in a fast paced, dynamic environment
• 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

People/Values

• Adhere to all HR Policies as appropriate
• Proactive engagement with key stakeholders.
• Best practices developed and shared with other teams /sites.
• Best practices actively sought and copied.
• Proactive and effective communication within and across shifts

Work Location Assignment: Hybrid
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

How to apply

• Make a difference today, all suitable candidates should apply with CV below. We are looking forward to hearing from you!

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.
Disability Inclusion
Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here!
Manufacturing
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