Standards Bioprocess Engineer

GSK•Upper Merion Township, PA

4d•Hybrid

About The Position

The Manufacturing Science and Technology (MSAT) organization is a site-based team, providing technical support to ensure Upper Merion Biopharm site goals and objectives are achieved. The primary objective role of MSAT is to ensure manufacturing processes are capable, compliant and productive while ensuring product quality. The site MSAT team is also responsible for delivering continuous improvements to the existing supply chains supported by UM Biopharm and working with global MSAT to execute technology transfers and implement process-related improvement programs across the product lifecycle. The MSAT standards bioprocess engineer will lead and support the creation, implementation and maintenance of technical standards for bioprocess operations for use at our Upper Merion commercial site. You will work with operators, engineers, quality and global standards teams to simplify processes and improve consistency. We value clear communication, practical problem solving and a willingness to learn. This role offers career growth, visible impact and a chance to help GSK unite science, technology and talent to get ahead of disease together. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

Requirements

Bachelor’s degree in biochemical engineering, chemical engineering, biology, biochemistry or chemistry, or related technical field.
Minimum two years’ post-graduate industry experience in technology/biopharmaceutical process development or biopharmaceutical manufacturing.
Legal right to work in the United States.
This role is on-site with a hybrid working pattern depending on site needs.
This role will require being on-site.

Nice To Haves

Practical knowledge of bioprocess operations such as upstream (large scale, cell banking, and/or small scale cell culture), downstream (bioseparations, purification technologies), and single-use systems.
Strong verbal and written communication skills.
Able to provide leadership to generate options to resolve problems, prioritize, and decide appropriate courses of action.
Effective at implementation decisions.
Strong collaboration skills and experience working with cross-functional teams.
Able to interact well with peers, subordinates, and senior personnel in scientific, quality, engineering and operational disciplines.
Familiarity with quality frameworks and regulatory expectations relevant to bioprocessing.
Knowledge of document control systems and digital tools for standards management.

Responsibilities

Develop, review and maintain clear procedural and technical standards on contamination control, single-use systems, cleaning validation, lifecycle management, leachable and extractables, and cell banking.
Serve as a technical enterprise leader across the Upper Merion site, to support investigations, global initiatives, risk assessments, technology transfers, and regulatory/audit across these key areas of responsibility.
Support management of the Upper Merion cell bank portfolio and key cell bank activities and documentation.
Maintain a strong partnership with global MSAT technical standards team to align practices and share improvements across sites.
Conduct gap analyses, propose practical corrective actions, and track closure with stakeholders.
Support internal audits, compliance checks and continuous improvement efforts.
Act as a primary contact for standards questions and support teams during changes.