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Engineer II / Senior Engineer
Process Engineering
Confirmed live in the last 24 hours
Research Triangle, Durham, NC, USA
Experience Level
Desired Skills
  • BS in Chemical Engineering, Bioengineering, Biochemistry, or equivalent with minimum 4-10 years of relevant work experience, or a M.S. degree with a minimum of 2-8 years of relevant work experience
  • Level will be commensurate with experience and academic background
  • Demonstrated technical expertise within downstream processing for production of large molecule biologics, gene, mRNA and/or LNP therapeutics (experience in CGT production is preferred)
  • 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
  • Provides technical and subject matter expertise for CGT processes/equipment in support of cGMP clinical and commercial manufacturing
  • 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 during initial site start up, which may include supporting critical operations outside of normal work hours, as needed
  • Must be able to work onsite
Beam Therapeutics

501-1,000 employees