Senior Engineer, Process Engineering
Beam has expanded our geographical footprint to RTP, NC with the addition of a 100,000 square foot manufacturing facility in addition to our laboratory-based facilities located in Cambridge, MA. Beam is seeking a highly energetic Process Engineer II / Senior Engineer in the Engineering & Facilities team to support site start up, and cGMP manufacturing operations, implementation of CGT based therapeutics at our new RTP site. The successful candidate will be responsible for providing operational and technical support for manufacturing (mRNA, LNP, Autologous & Allogeneic processes) and basic utilities processes within the site.
The Process Engineer will provide technical support and develop into subject matter expertise for CGT processes/equipment in support of cGMP clinical and commercial manufacturing as well as support for CapEx project work and internal technology transfers. As a key hire within the new RTP site, this role will play a key role supporting the startup of equipment and developing expertise and relationships with vendors. As the site transitions to clinical and future commercial cGMP production of therapeutics, this role will provide technical support to manufacturing, contribute to the readiness for process validation, and provide process technical support. Additionally, this role will be a key role in communications between engineering and other core groups including Manufacturing and Quality.
- Provides technical and subject matter expertise for CGT processes/equipment in support of cGMP clinical and commercial manufacturing. Initial focus with mRNA and LNP programs in a Responsible Engineer (RE) function.
- Own and manage small CapEx and process improvement projects for the Engineering and Facilities team. Support role for site expansion projects as the site Lead Process Engineer.
- Leads or contributes to the establishment of technical documentation including project documents, equipment Preventive Maintenance and Calibrations, standard operating procedures, process validation plans/protocols/report, risk assessments, etc.
- Supports facility and equipment design and qualification to meet process and regulatory expectations.
- Support deviation and change control generation, review, and execution.
- Supports regulatory reviews and responses, audits and regulatory inspections, as required.
- Represents the Engineering team within cross functional project teams as required.
- Leads and/or assists with manufacturing deviation investigations and change controls.
- Provides Person-In-Plant (PIP) support to manufacturing, as required.
- Establishes and maintains strong relationships at the site and cross-functionally.
- Travel is expected to be up to 5% of the time for in-person interactions with cross-functional partners and trainings.
- Must be willing to have a flexible schedule which include but not limited to supporting projects and critical operations outside of normal work hours.
Required Experience & Qualifications:
- BS in Chemical Engineering, Bioengineering, Biochemistry, or equivalent with minimum 8-10 years of relevant work experience, or a M.S. degree with a minimum of 6-8 years of relevant work experience.
- Level will be commensurate with experience and academic background.
- Demonstrated technical expertise within mRNA and/or LNP therapeutics (experience in CGT production is preferred), downstream processing for production of large molecule biologics, gene therapy.
- Prior hands-on purification development experience preferred.
- Basic utility equipment and processes preferred.
- Strong background in drug development and regulatory requirements, fluency in process validation lifecycle requirements.
- Experience successfully leading manufacturing event investigations, Root Cause Analysis (RCA), and CAPA.
- Outstanding written and verbal written communication skills, with the ability to convey strategies and results to a diverse audience.
- Dynamic interpersonal skills and the ability to manage through influence.
- Ability to juggle multiple projects and priorities and adapt quickly to changing circumstances.
- High degree of customer focus (internal/external) and demonstrated collaboration in a team environment.
- Results oriented with the ability to demonstrate resiliency, ownership, and drive.