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Job Description

A large pharmaceutical company in Springhouse, PA is seeking a GMP Operations Process Engineer. This role acts as the technical bridge between process development and GMP manufacturing. The engineer supports floor‑level manufacturing teams by executing the activities required to transfer processes into GMP production, including configuring data flows, ensuring data integrity, and managing all aspects of tech transfer. They serve as the subject matter expert for all technical activities occurring between development handoff and full GMP execution.

In this role, you will provide project management, engineering oversight, and manufacturing support. Key responsibilities include developing project plans, coordinating cross‑functional teams, and managing the product lifecycle—from early development through clinical production—for life‑saving autologous cell therapy products.

Key Responsibilities

Technical and manufacturing integration of new processes from R&D into the supply chain (cell therapy products or any other advanced therapy products).

Strong organizational, communication and project management skills. Manage, support and provide oversight to support systems and processes.

Providing required manufacturing technical support, documented technical input, review, and approval and troubleshooting as the technical expert.

Understand and have a strong knowledge of cGMPs, FDA and other advance therapy regulations, sterile/aseptic processing.

Designing and leading cycle development technical studies, as applicable, for various technical equipment including isolators, controlled rate freezers, etc.

Create and maintain documentation such as batch production records, operational procedures, criticality analysis, user requirements and key and controlled parameter documents.

Apply appropriate risk management tools such as FMEA, HAZOP, and business risk assessments to maintain and/or improve operational safety and quality.

Involvement with plant process control systems and use these systems/tools to monitor and improve the processes within scope.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [email protected] learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

Skills and Requirements

- Minimum of a bachelor’s degree required with 6-8 years’ experience; focused degree preferred in Engineering, Supply Chain, Chemistry, or life sciences.

- Experience supporting GMP manufacturing operations and working within regulated environments.

- Knowledge of Tech Transfer, PF2P, facility design to ensure GMP readiness for clinical programs.

- Hands‑on involvement with tech transfer from development to GMP production.

- Strong aseptic processing knowledge.

- Ability to configure and maintain process data flows while ensuring strong data integrity.

- Strong troubleshooting skills to resolve issues between process development handoff and floor execution.

- Effective cross‑functional communication with development, MSAT, engineering, and manufacturing teams.