Manager, Plant Engineer

Site Name: Cambridge Binney Street Posted Date: Dec 18 2022 We need fresh thinking to get ahead of disease Our Commercial, Vaccines, Research and Development (R&D), and Global Supply Chain businesses help the world prevent and treat disease every day. Getting ahead means preventing disease as well as treating it. It means innovating together, fusing ideas, capabilities, and know-how inside and outside of GSK. Nevertheless, we remain committed to keeping ahead of issues that matter for the sustainability of our company, be it pricing and access, the environment, or stronger diversity and inclusion. Our Global Supply Chain is responsible for every stage of production, from the infrastructure of our 28 sites in 16 countries, to forecasting supply, and ensuring the quality of every product. Over the past three years, we’ve increased productivity by over 20% as we build an agile network that delivers the next generation of medicines for patients. We have an exciting new opportunity to join the team as a Manager, Plant Engineering. Reporting to the Associate Director Project and Plant Engineering, you will be responsible to support ongoing operations at the Binney Street, MA, site through technical assistance as it relates to manufacturing and process systems. The focus of the role is on ensuring manufacturing equipment and facilities are operating as intended to meet the requirements for biopharmaceutical manufacturing. Key Responsibilities Provides engineering support required for specific assigned utility infrastructure, systems and equipment. Provide SME support to Manufacturing and other departments for the design and operation of process or laboratory equipment Conduct troubleshooting and technical analyses on equipment and processes including data analyses, automation review, MOC analyses, flow path analyses, etc. Provides technical support for equipment ensuring continued compliance to regulatory, company and site policy and procedure. Author, execute and lead commissioning protocols (installation, operation, CIP/SIP, wet testing) Participate in FMEA and RCA events to ensure proactive approach to risk mitigation, and identification of true root cause and preventative actions. Engineering SME to support tech transfer of new processes into the facility Author and drive completion of Quality documents example Deviations, Change Controls, CAPA, OTN, Batch Release change control assessments etc Participates in audits and inspections as engineering SME As required during construction of future projects, responsibilities will include supporting project group with developing scope and justification, design reviews, assistance in the preparation of specifications, execution, and evaluation of factory acceptance tests for utility equipment, assessment of spare part requirements, assist in the generation of PM activities, and walk down of equipment systems prior to handover. Review of as built drawings and TOP. Ability to understand, implement, and monitor regulatory and safety guidelines applicable to the pharmaceutical industry. Why you? Basic Qualifications: 4+ years relevant experience in GMP biopharmaceutical industry in a role related to plant equipment, utilities, and systems GMP experience and safety expertise (understanding of OSHA requirements) Understanding of design principles and standards within Bio-pharmaceutical facilities. Ability to look at plant problems and come up with options for solutions. Ability to develop alternative courses of action that are based on logical assumptions, factual data and engineering principles. Demonstrated track record of contribution to successful regulatory inspections Strong interpersonal, communication, negotiation, and analytical skills. Understands the impact the role has to safety, quality and delivery of business results. Works with a Right First Time mindset in daily responsibilities and acts with a sense of urgency when addressing issues that are risk to product. Demonstrated ability to work well with other departments, lead in a cross functional team environment and deliver results in a global matrix organization. Proven ability to manage multiple priorities in a fast-paced environment Proficient with Outlook, Word, PowerPoint, Excel Visio. Proficiency with data systems such as DeltaV, SCADA, PI or equivalent is preferred. Ability to effectively communicate via writing and oral communication at all levels to both internal and global stakeholders. Express ideas effectively in individual and group situations (including non-verbal communication). Ability to communicate to communicate technical information to both technical and non-technical people. Work outside business hours may be required for support of ongoing 24/7 manufacturing facility. Preferred Qualifications: B.Sc Engineering (Chemical or Mechanical preferred), or equivalent.
GSKBinneyStreet
LI-GSK Why GSK? We want GSK to be a workplace where everyone can feel a sense of belonging and thrive. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. 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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. 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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve. GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site.