About The Role:
The Associate Process Engineer (Drug Product) is an entry level technical contributor within Manufacturing Science and Technology (MS&T), responsible for supporting implementation and sustainment of biopharmaceutical equipment and processes supporting gene therapy manufacturing. This role supports equipment and process introduction, technical transfer activities, engineering studies, and troubleshooting under the guidance of senior engineering staff to ensure systems are fit- for-purpose and ready for operations. This is a highly collaborative role that works closely with cross-functional teams including Process Development, Manufacturing, MSAT Operations, Validation, Quality, and external partners to ensure processes are scalable, robust, and aligned with global regulatory expectations.
Responsibilities:
- Support execution engineering studies to evaluate equipment performance, optimize process parameters, and assist with engineering controls supporting operational readiness.
- Assist with authoring and revising technical documentation including engineering studies, SOPs, protocols, and technical reports.
- Support technology transfer activities including documentation support, process flow mapping, and participation in risk assessments.
- Support commissioning and qualification activities including equipment documentation (URS), factory acceptance testing (FAT), site acceptance testing (SAT), commissioning, and vendor IQ/OQ.
- Support equipment troubleshooting activities and vendor interactions under guidance of senior engineering staff.
- Provide technical support to Manufacturing for routine operations, new process implementation, and equipment readiness activities.
- Support investigations related to process or equipment performance and assist with implementation of corrective actions.
- Ensure processes meet all regulatory guidelines (FDA, EMA, ICH, etc.) and quality system requirements (cGMP).
- Build collaborative working relationships with internal stakeholders to drive the business towards achieving company objectives.
- Exhibits professional behavior consistent with company policies and cultural values.
- Additional responsibilities not listed may be assigned as needed by management
Qualifications:
- Bachelor’s degree, in life sciences, engineering or related field and 1+ years of experience, Master’s degree with 0-1+ years of experience
- Demonstrates foundational technical knowledge in at least one focus area related to drug substance and/or drug product manufacturing, process or utility equipment, or automated systems.
- Demonstrated basic ability to interpret and utilize technical documentation including engineering drawings, piping and instrumentation diagrams (P&IDs), SOPs, vendor documentation, and equipment manuals.
- Strong organization and communication skills
- Strong attention to detail and ability to maintain accurate GMP documentation
- Commitment to following SOPs, safety protocols, and regulatory guidelines to ensure compliance and product quality.
Preferred Qualifications:
- Prior experience in biologics or gene therapy manufacturing.
- Familiarity with electronic documentation systems or data analysis tools.
Physical Requirements:
This position works in both a laboratory environment and typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. The employee will be stationary (standing/sitting) occasionally. Employees may need to wear clean room gowning or personal protective equipment based on the task being performed. Must be able to work in a confined space, such as a clean room or laboratory environment. Ability to identify small details within the field of vision, distinguish between different colors, and accurately identify objects within a specific area.
