Process Engineer

GSK • Rockville, MD

8h

About The Position

The Process Engineer’s function at the Rockville Biopharm site is to provide technical engineering and project management services for cGMP manufacturing operations including capital project management, equipment optimization and tech transfer support. Motivated engineering professional who can manage small to medium projects while supporting manufacturing operations . This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Provide engineering support for the design, testing and optimization of biopharmaceutical manufacturing equipment up to 20,000L scale including stainless and single-use bioreactors, centrifuges, chromatography systems, filtration skids, pasteurizers, chromatography skids, etc. Manage capital projects and engineer solutions involving retrofits, modifications and acquisition of process equipment. Support execution of technology transfer and scale-up activities. Lead resolution of technical issues with manufacturing operations and equipment. Collaborates with other manufacturing support groups including Validation, Automation, Quality, Metrology, Maintenance and Process Development. Applies knowledge of process and utility systems to make recommendations to improve manufacturing systems, equipment and process efficiencies. Experience with project management (schedule, cost, communications) and coordination of internal and external resources to execute projects in a timely and cost-effective manner. Subject matter expert (SME) and equipment owner for Upstream and/or Downstream process equipment with ability to assist in the execution of design, procurement, testing (FAT, SAT, commissioning), installation and validation activities. Capable of negotiating contracts, bids, and change orders with vendors or contractors. Support investigations and recommend solutions with key stakeholders in order to gain a consensus on effective corrective and preventive actions (CAPA). Why you? Basic qualifications: BS in Engineering or related technical discipline such as Biological, Chemical, Mechanical . 2+ years of experience working in a regulated cGMP biopharmaceutical environment. Preferred Qualifications : Experience with technical risk assessments and product control strategies. Capable of working in a collaborative and team focused environment. Demonstrated understanding of the product development process. Able to evaluate potential innovative technology areas relevant to products. Experience supporting batch and continuous industrial control systems. Change control and deviation management experience. Must be proficient with common business enterprise technologies including MS Office. Working knowledge of biopharmaceutical production, quality systems and clinical or commercial manufacturing including cell culture and/or microbial processes. Demonstrated ability to participate as a member of a cross-functional team. Basic understanding and knowledge of biopharmaceutical production equipment including but not limited to bioreactors, centrifuges, CIP skids, chromatography systems and filtration skids. Project management experience, including the ability to manage a project by delivering scope, cost and schedule. If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $89,925 to $149,875.

The US salary ranges take into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.

If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process. 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 purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at [email protected] where you can also request a call. Please note should your inquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide. Click the link where you will find answers to multiple questions we receive GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. 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 the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/

Requirements

• BS in Engineering or related technical discipline such as Biological, Chemical, Mechanical
• 2+ years of experience working in a regulated cGMP biopharmaceutical environment.
• Must be proficient with common business enterprise technologies including MS Office.
• Working knowledge of biopharmaceutical production, quality systems and clinical or commercial manufacturing including cell culture and/or microbial processes.
• Demonstrated ability to participate as a member of a cross-functional team.
• Basic understanding and knowledge of biopharmaceutical production equipment including but not limited to bioreactors, centrifuges, CIP skids, chromatography systems and filtration skids.
• Project management experience, including the ability to manage a project by delivering scope, cost and schedule.

Nice To Haves

• Experience with technical risk assessments and product control strategies.
• Capable of working in a collaborative and team focused environment.
• Demonstrated understanding of the product development process.
• Able to evaluate potential innovative technology areas relevant to products.
• Experience supporting batch and continuous industrial control systems.
• Change control and deviation management experience.

Responsibilities

• Provide engineering support for the design, testing and optimization of biopharmaceutical manufacturing equipment up to 20,000L scale including stainless and single-use bioreactors, centrifuges, chromatography systems, filtration skids, pasteurizers, chromatography skids, etc.
• Manage capital projects and engineer solutions involving retrofits, modifications and acquisition of process equipment.
• Support execution of technology transfer and scale-up activities.
• Lead resolution of technical issues with manufacturing operations and equipment.
• Collaborates with other manufacturing support groups including Validation, Automation, Quality, Metrology, Maintenance and Process Development.
• Applies knowledge of process and utility systems to make recommendations to improve manufacturing systems, equipment and process efficiencies.
• Experience with project management (schedule, cost, communications) and coordination of internal and external resources to execute projects in a timely and cost-effective manner.
• Subject matter expert (SME) and equipment owner for Upstream and/or Downstream process equipment with ability to assist in the execution of design, procurement, testing (FAT, SAT, commissioning), installation and validation activities.
• Capable of negotiating contracts, bids, and change orders with vendors or contractors.
• Support investigations and recommend solutions with key stakeholders in order to gain a consensus on effective corrective and preventive actions (CAPA).

Benefits

• health care and other insurance benefits (for employee and family)
• retirement benefits
• paid holidays
• vacation
• paid caregiver/parental and medical leave
• annual bonus
• eligibility to participate in our share based long term incentive program which is dependent on the level of the role

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level