13 days old

Process Scientist (Technical Operations)

Pfizer
Grangeville, ID 83530
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**Process Scientist (Technical Operations)**



This is a time like no other at Pfizer! We are now pushing the boundaries of what's possible.



Pfizer Grange Castle, one of the largest integrated biopharmaceutical plants in the world is to start producing supplies of the Covid 19 Vaccine.Up to $40m will be invested in our manufacturing facility which will lead tothe creation of a diverse set of roles across ourbusiness. The Grange Castle facility will now produce the mRNA drug substance, making it only the second plant in our network to do so.



If you are an experienced Process Scientist, this is a fantastic opportunity to join us on our journey to manufacture breakthroughs that changes patients' lives! Together we will ensure that Science will win.



**About the role:**



+ This role is to support the completion of validation activities and support of license application US / EMEA for next generation multivalent Meningococcal Conjugate Vaccine

+ Completion of on-going Process Validation Activities, compilation of validation supporting data and write up of process validation reports and ancillary validation reports (resin lifetimes, filter validation, comparability reports etc..) in accordance with current cGMP and Pfizer quality standards (including PQS).

+ The role requires close liaison with Vaccines development organization & Pfizer CMC on Product filing.

+ Provide SME leadership to the project on significant validation issues in support of project milestones and major investigations.

+ Provides SME expertise and guidance on validation and qualification life cycle requirements as defined by regulatory and Pfizer quality standards and procedures e.g. Risk assessments, Control Strategies, Validation Plans, GMP requirements, SME input to verification testing and validation summaries including deviations and change controls.

+ The role requires liaison with stakeholders and partners in Operations, Manufacturing Sciences and Technology (MSAT), Quality and Regulatory functions.



**About you:**



+ A senior technical SME in biopharmaceuticals with good knowledge of current cGMP's and other regulatory guidance's (ICH Guidelines, EMA Annex 15, FDA PV guidance 2011, etc.). Broad experience across a range of technical areas would be advantageous e.g. cell culture, vaccines conjugation, clinical and commercial production, etc.

+ Excellent communication skills to liaise with senior stakeholders across site and the Biotech OpU are key requirement.

+ A minimum of 5 years' experience providing validation and/ or license application support.

+ Validation leadership working in biopharmaceuticals is preferable. Experience of presenting complex technical issues in cGMP audits and inspections would be an advantage.

+ Previous experience of process validation execution with Pfizer or in other biopharma companies is preferable.

+ Experience of working with cGMP systems in the biopharmaceutical industry is required, particularly in making complicated product quality impact assessments.

+ Experience delivering significant work packages for major process tech transfers

+ Strong evidence of problem-solving/trouble-shooting skills

+ Knowledge of good bioprocess equipment design.

+ A minimum of a B.Sc., B.E. or M.Sc./M.Eng. Degree in Biosciences or Biochemical/ Chemical Engineering or equivalent. Qualifications in bioprocess or analytical-related disciplines preferred.



**What We Offer?**



Permanent position with Competitive Salary and Shift Allowance plus Bonus Schemes, Healthcare for you & your family, Pension & Share Scheme, Long term Income Protection, Life Assurance, Option to buy Additional Annual Leave days.



Grange Caste is close to the M50 and offers free parking and subsidized canteen onsite.



**Our Culture**



Our Culture in Grange Castle is hugely important to us. We recognize that people are the cornerstone of Pfizer's success. We embrace career development & colleague engagement. As a team, together we run our business, so your input and expertise are essential to our success!



We run regular EXPOs onsite such as Kids 2 Workday, Day in the Life and Health and Wellbeing initiates. We have a Site Culture Team and a varied Sports and Social Club.



Our safety is at the heart of everything we do. We strive to be free of injuries and incidents because we care about everyone here



Our culture is founded on the pillars of Equity, Joy, Courage and Excellence



**How to apply**



Make a difference today, all suitable candidates should apply though the link with CV provided. We are looking forward to hearing from you!



**Additional Detail**



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

+ Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

+ Due to high volume of applications we will be contacting successful candidates only



**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.



Engineering
Posted: 2021-06-11 Expires: 2021-07-15
Sponsored by:
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Process Scientist (Technical Operations)

Pfizer
Grangeville, ID 83530

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