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Homology Medicines, Inc. Senior Process Engineer I in Bedford, Massachusetts

Homology is searching for a Senior Process Engineer I to be a member of our Manufacturing Operations team. This key team member will provide engineering support of day-to-day clinical manufacturing operations. The Senior Process Engineer I will be responsible for the system ownership and project execution of process and utilities equipment, including troubleshooting process equipment, managing project execution, leading project commissioning and qualification activities, and optimizing process and utilities equipment within a regulated cGMP facility. This team member will lead project lifecycle (conceptual design, specification, design and verification, installation and acceptance, and maintenance) activities for process and utilities equipment for cGMP production. The Senior Process Engineer I will be asked to develop solutions and best practices for a variety of problems large complexity projects, and must be able to manage relationships with Quality, Manufacturing, Facilities, Product Development, external supply partners, and with vendors. This key role offers the opportunity to actively take part in the application of our technology platform to improve the lives of patients.

Project Support

  • Manage Engineering responsibilities and report progress to management for engineering testing, commissioning, and qualification activities.

  • Responsible for all aspects of Engineering design and installation by working with external supply partners, design firms, and contractors.

  • Ensure all project documentation is accurate and up to date (P&lDs, mechanical system drawings, automation documentation, etc.).

  • Compile and Review equipment Engineering Turnover Packages (EToPs) for executed projects.

  • Responsible for ensuring all equipment is walked down and revised for all types of engineering drawings.

  • Work with a cross-functional groups to develop requirements and recommendations for system/facility modifications.

  • Lead troubleshooting and remediation of exceptions found during process operations and technology transfers.

  • Accountable for all phases of the engineering lifecycle.

  • Define all aspects of project scope and project activities.

  • Develop and mentor junior engineers on Good Engineering Practices (GEP).

Operational Support

  • Provide ownership of the single use materials program for the operations group with emphasis on specifications related to single use materials, supplier management and sourcing strategy, Extractables and Leachables testing and profiling, as well as inspection.

  • Partner with multiple functions to ensure appropriate systems are in place that are needed to support cGMP operations, with a keen focus on single use technologies.

  • Collaborate with manufacturing personnel regularly about standard practices and procedures for process and utilities equipment/automation design and operation.

  • Lead the technical support for SOP changes, Deviations, GMP Investigations and CAPAs.

  • Manage working relationships with process development, manufacturing, quality, facilities, procurement to proactively address process and performance problems.

  • On-call support for all active process equipment and manufacturing activities.

  • Accountable for the timely resolutions of safety related design/equipment issues.

  • Own process equipment and single-use technologies for GMP manufacturing.

  • Re-engineer unit operations, equipment, and manufacturing areas to meet end-user's needs.

  • Accountable for troubleshooting activities, equipment design, and specifications for equipment (including single use) and instrumentation.

  • Determine corrective maintenance actions, collaborates on preventative maintenance, works to identify spare parts for process and utility equipment.

  • Provide guidance to maintenance personnel and actively participates in the decision making and project execution of process and/or design improvement.

  • Own and ensure timely closure of equipment corrective and preventative actions.

Documentation, Standards and Templates

  • Write, review, and approve equipment specifications, engineering procedures and protocols.

  • Assist in the revision of manufacturing documentation (SOPs, BR, etc.).

  • Actively manage engineering drawings by coordinating and executing redlines, reviews, and revisions.

  • Bachelor’s degree in an Engineering field or equivalent scientific background, with a minimum of 5 years of directly relevant industry experience in a cGMP engineering environment required, or equivalent years of directly relevant industry experience in a cGMP engineering environment required.

  • Hands-on expertise with bioprocess engineering and knowledge of disposable applications in a biologics process.

  • Experienced with single use materials, including but not limited to specifications, supplier management and sourcing, Extractables and Leachables testing and profiling, and inspection.

  • Exceptional verbal and written communication skills, organizational skills, as well as interpersonal skills are essential.

  • Must be a team player able to embrace a team-based culture and to lead a diverse team with diverse skill levels.

  • Able to accommodate rapidly changing priorities and deadlines.

  • Demonstrated ability to collaboratively solve complex process and equipment problems.

  • Critical thinker with demonstrated ability to solve problems of complex scope.

  • Accountable for establishing and maintaining working relationships with internal departments and external supply partners.

  • Proficiency with Microsoft Office products and ability to learn additional software applications, as needed.

  • Capable of defining requirements based on industry practices, techniques, and standards.

  • Capable to defining department prioritization based on rapidly changing priorities and deadlines.

  • Experienced in engineering, facility design, automation, or related disciplines.

  • Familiar with biotechnology single-use system and stainless-steel process equipment.

  • Competent with domestic and international GMP regulations.

Job ID: 2022-1196