Company Overview:

Beam Therapeutics is a clinical stage biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform that includes a suite of gene editing and delivery technologies and is in the process of building internal manufacturing capabilities. Beam’s suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of potential therapeutic editing strategies that Beam has used to advance a diversified portfolio of base editing programs, including four programs to the clinic. Beam’s lead program, BEAM-101 has recently demonstrated clinical validation in Sickle cell disease through upregulation of fetal hemoglobin in patients. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases.

Position Overview:

The Sr/Principal CQV Engineer will be critical to the success of Beam’s overall internal manufacturing and testing strategies. The position can be located in RTP, NC, or Cambridge, MA and will spend time at both locations (~25% travel). Both locations have existing GMP facilities that require support for CAPEX and Opex activities to make sure that the equipment and instrument qualification programs are operationally efficient without compromising the CQV program’s compliance posture.

The role will work closely with MA and NC CQV Managers, as well as System Owners, ENG/Facilities, IT and QA partners at both the NC and MA sites to build and continuously improve CQV support for facilities, utilities, equipment, and analytical instrumentation. The Sr/Principal CQV Engineer may help develop program strategies, validation approaches for complex equipment, provide project management support for critical CQV program initiatives, oversight or guidance for new team members, and defend validation packages during audits. The position will report through Beam’s Technical Operations-Validation group.

Responsibilities:

• Provide leadership to both sites on the various aspects of a compliant CQV program to support both capital projects and maintenance of the validated state for facilities, utilities, equipment and computerized systems, including analytical instruments.
• Support key capital projects, providing routine updates on CQV progress and support issue escalation and resolution
• Support implementation of a validation package periodic review/re-evaluation program for assets at both sites
• Assist CQV Managers with CQV estimates for capital projects or significant Opex initiatives.
• Lead continuous improvement initiatives for the overall CQV program
• Must be able to work onsite.

Qualifications:

• Bachelors or Advanced degree in an engineering or scientific discipline.
• 12+ years years’ experience in the biopharmaceutical/biotech industry supporting internal manufacturing and testing operations in a validation or technical operations/engineering capacity
• Project Management experience and skills preferred
• Experience supporting CQV work for small and large capital projects preferred
• Experience supporting periodic review / requalification/reevaluation programs for facilities, utilities, equipment and computerized systems preferred
• Excellent verbal and written English language communication skills, detail-oriented personality, and ability to work and drive change across functions.
• Solid knowledge of global facility, utility, equipment and computer system regulations and standards; experience interacting with regulatory health authorities at pre- and post-approval inspection is preferred.
• Experience with Lifecycle management software, experience with Kneat preferred.
• Strong team player that has a customer service approach and is solution oriented.
• Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
• Excellent team building, leadership and management skills.
• Excellent listening, communication and interpersonal skills fostering team spirit.
• Consistent delivery of on-time high-quality work
• Ability to gown and enter clean rooms (i.e. GMP manufacturing spaces).