Process Engineering Manager

Are you interested in leading a team responsible for engineering at an important drug substance and drug product manufacturing site? Are you interested in delivering innovative technology and building a team to be successful? If so, this Process Engineering Manager role could be an excellent opportunity for you to explore.

*The position has the flexibility to be performed as a Secondment or Full-time opportunity. The Hiring Manager will discuss additional details on options available during the interview process*.

As a Process Engineering Manager, you will be responsible for leading the team responsible for engineering of equipment and facilities for the manufacture of biological drug substance and sterile drug product. Engineering team responsibilities include the design, delivery, construction, start-up, and qualification of process equipment and areas including drug substance purification, drug product formulation, filling, assembly, and packaging. Responsibilities are by first intent for projects executed within the US. Fluency in (bio)pharmaceutical processes, facilities, operations, engineering methods, and GSK standards in project management, operations, quality, and EHS are essential. Individual management of individual processes and equipment also foreseen.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

• Lead a team of process engineers who are individual experts in area specific bioprocess equipment and facility design / operation.
• Deliver new equipment and processes into the facility – including drug substance unit operations such as buffer preparation, UFDF, mixing, and homogenization and drug product unit operations such as formulation, filling, assembly, and packaging.
• Support the construction, commissioning, qualification, and 24/7 manufacture of vaccines and medicines critical to patient quality of life and support critical revenues for the company. On-call support for manufacturing troubleshooting and planned upgrades is a team necessity.
• Fluent in biopharma industry standards for equipment and facility design for cleanability and bioburden control. Expert in CIP/SIP design and operational principles. Familiar with statutory guidance for above (ASME BPE, ISPE). Fluent in sterile fill industry standards for equipment and facility design.
• Manage efforts and resources required by project teams to meet technical, budget, and schedule goals. Expert in multi-tasking, scheduling, budgeting, and project management. Familiarity with equipment supplier, preferred subcontractor, and consultant engineering markets to support site projects as needed with competitive cost and service.
• Interface with Automation, Environmental, Health & Safety, MSAT, Manufacturing, Quality, and Corporate Engineering groups to assure that each project conforms to approved user requirements.
• Guide / mentor / coach team as they deliver equipment and facility packages - support their generation of possible solutions and the selection and buy-in of the final solution. Follow-up to ensure the solution is implemented appropriately and satisfies the customer's requirements.
• Develop high-performing engineers into experienced leaders and experts in manufacturing capable of leading the business outside engineering.
• Ensure EHS corporate standards, local legislation, and other Quality and Regulatory requirements are included while planning and executing all projects. Also, ensure proper identification and assessment of potential EHS risks that are significant to the business and that can be eliminated or minimized before or during project implementation.

We are looking for professionals with these required skills to achieve our goals:

• Bachelor's degree in engineering or equivalent technical discipline.
• 10+ years in Engineering and Plant Operations
• Experience with biopharmaceutical equipment and manufacturing processes.
• Experience managing capital and systems subject to audits from regulatory bodies.

If you have the following characteristics, it would be a plus:

• Master's degree in engineering
• 10+ years of prior project and/or process engineering experience in the pharmaceutical industry is preferred.
• Prior project experience in the design, construction, start-up and operation of large bulk biopharmaceutical drug substance AND drug product fill / finish facilities.
• Demonstrated ability to manage projects >$10m to completion on time and within budget (minimum), preference for >$50m.
• Familiar with cGMPs, GEPs.
• Detailed understanding of Design, Installation, and Commissioning / Qualification / Validation of new pharmaceutical equipment and/or utilities.
• Must be able to interact well with peers, subordinates, and senior personnel in scientific, engineering, and operational disciplines.
• Demonstrated ability to participate as a leader or member on cross-functional and self-directed work teams.
• Must be comfortable and thrive in ambiguity and think strategically to solve complex problems.
• Sense of Urgency / Decision making.
• Strong interpersonal skills.
• Must be able to work within a multi-disciplinary team environment.
• Must be able to generate options to resolve problems, prioritize solutions and implement decisions.
• Must be competent in handling simultaneously occurring tasks and have excellent written and oral communication skills.
• Project Management Professional Program Certification or Professional Engineer license

#LI-GSK

#Supplychaincritical

#MariettaGSC

#MariettaVaccines

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.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at US Toll Free) or 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.

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.