Your Role:
This position is in the Manufacturing Science and Technology team (MS&T) team. The Process Engineer II, MSAT is responsible for providing technical support to manufacturing operations, ensuring robust, efficient, and compliant production processes. This role is a key interface between internal (Process Development) / external (Clients) and Manufacturing, with a focus on technology transfer, process optimization, and troubleshooting.
This position is responsible for assisting Technology Transfer (TT) of processes, authoring of technical documentation, risk assessments, implementation of GMP documentation (batch records and SOPs) and managing manufacturing related quality events (change controls, deviations, CAPAs) and investigations.
Additionally, this position will collaborate closely with internal and external stakeholders establishing partnerships to ensure compliance with cGMP and Quality Management systems to deliver our services to the clients effectively.
Essential Duties and Responsibilities:
- Assist in technology transfer activities from process development to manufacturing, including preparation of documentation and support during execution.
- Manages/Support timely completion of Manufacturing related Quality Events (QEs) such as deviations, investigations, CAPAs, and Change Controls.
- Coordinate the development, writing, collaboration and review of Standard Operating Procedures (SOPs), Standard Manufacturing Procedures (SMPs), Batch Production Records (BPRs) and other GMP documentation.
- Investigate and troubleshoot process deviations, non-conformances, and equipment issues.
- Participate in or lead root cause investigations and implement CAPAs.
- Assist design and execution of process validation and qualification documentation (e.g., PPQ).
- Analyze process data to identify trends, drive improvements, and ensure control strategies are effective.
- Collaborate cross-functionally with QA, QC, Validation, and Manufacturing teams.
- Provide technical support during audits and regulatory inspections (e.g., FDA, EMA).
- Contribute to lifecycle management of processes including scale-up, tech transfer, process changes, raw material assessments and supplier qualification.
- Work in a cross-functional matrix environment and collaborate with internal and external functions including Regulatory and Quality teams.
- Be accountable for the success of company and department projects/activities and ensure on-time deliverables to meet program commitments. Prepare periodic reports and present data to internal and external stakeholders as needed.
- Knowledge management by preparing templates, procedures, and effective training to ensure process are effectively transferred to the operations team.
- Work with operations team to create a culture of accountability, ownership, and continuous improvement.
- Respect all safety, laboratory policies, and practices on site.
- Work across departments and/or sites.
- Work with process engineers and manager to align the priorities of the team with those of the department.
- Able to work independently; shows initiative and able to work with all levels of staff.
Requirements:
- Bachelor's degree in these same disciplines and a minimum of 5 years of relevant and progressively responsible experience in these same areas. Or Master's in science/chemical engineering or related field and a minimum of 3 years of progressively responsible experience in biologics/gene therapy manufacturing, MS&T or AS&T roles. At least 5 years of related experience in a GMP biologics manufacturing environment
- Previous GMP experience in handling deviation, change controls, CAPA using appropriate quality system is required.
- Excellent oral and written communication skills. Strong technical writing ability required.
- Ability to work cross functionally within the organization as part of a project team.
- Prior cell therapy experience is highly preferred.
- Involvement in prior manufacturing process tech transfer is preferred.
- Work experience in biologics for late-stage and commercialization of products with a good understanding of GMP operation is required.
- Work in a cross-functional matrix environment and collaborate with internal and external functions including Regulatory, and Quality teams.
- Demonstrated proficiency with regulatory requirements, USP, and ICH guidelines.
- Experience in using the statistical analysis tools (e.g. JMP) and/or sufficient knowledge of statistical concepts required to evaluate trends.
Skills:
- Excellent communication skills with good technical writing skills with a proven ability to work with internal and external partners
- Project management skills including planning, execution, risk and change management
- Good interpersonal and communication skills
- Effective team player
- Analytical skills with logical thinking problem solving skills
- Good knowledge of Microsoft office
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.
Work Environment:
This job is performed in a temperature-controlled facility without exposure to extreme hot or cold temperatures. Generally, this j