Posted:
10/7/2024, 5:56:14 AM
Location(s):
Massachusetts, United States ⋅ Cambridge, Massachusetts, United States
Experience Level(s):
Mid Level ⋅ Senior
Field(s):
Product
Are you energized by driving process improvement and leveraging your technical expertise in a world class manufacturing environment? If so, this Process Engineering Manager role could be an exciting opportunity to explore.
As Process Engineer Manager, you will be responsible for effectively managing change, identifying and mitigating risks, and ensuring critical control parameters are built into the site standard work and quality critical attributes are continuously monitored.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…
Technical expert in drug product process step especially in visual inspection and lead testing.
Bring technical support for any product transfer and/or contract manufacturing activity.
Knowledge of regulatory standards relevant to the dose form.
Practical understanding of Technical Risk Assessment (TRA) supporting development and use of Product Control Strategies for new and mature products.
Technical Risk Escalation and maintenance of knowledge management associated with drug product.
Capable of problem-solving technical issues relating to the dose form/product using process analysis tools such as Root Cause Analysis.
Ability to lead process improvement projects on site, manage technical change to deliver robust and sustainable solutions.
Support standardization of manufacturing
Support technology transfer for respective products from R&D into Global Manufacturing & Supply and subsequent transfers to other sites.
Design equipment processes and solutions (including cleaning) to enable robust and reproducible manufacture of the product
Advice on commissioning and performance pre-qualification tests, mentor some commissioning or qualification (FAT/SAT/IQ/OQ)
Increase knowledge and skills of self and site team with ability to coach, teach and develop.
We are looking for professionals with these required skills to achieve our goals:
Bachelor’s degree qualification in process engineering sciences, and/or academic level in life sciences in general
Experienced in the fast-moving Consumer Goods or Pharmaceutical industry
If you have the following characteristics, it would be a plus:
This individual should be able to operate with a good level of autonomy, need a good knowledge in science and good analytical thinking. The position requires a flexible and open mindset to new situations and to adapt to new approaches.
Post Graduate Degree.
Experience with Technology Transfers, Technical Risk Assessments, and Product Control Strategies.
Clear awareness of process safety risks.
Demonstrated understanding of the product development process.
Able to evaluate potential innovative technology areas relevant to products.
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Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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Website: https://gsk.com/
Headquarter Location: London, England, United Kingdom
Employee Count: 10001+
Year Founded: 1929
IPO Status: Public
Last Funding Type: Grant
Industries: Biotechnology ⋅ Health Care ⋅ Pharmaceutical