Process Engineer -Downstream

Employer
Homology Medicines
Location
Bedford, Massachusetts (US)
Posted
May 29, 2018
Ref
MFPE-0023-18
Required Education
Masters Degree/MBA
Position Type
Full time

Process Engineer -Downstream

Location: Bedford, MA

Job Code: MFPE-0023-18

 

Homology Medicines is searching for a Process Engineer to be a member of our Manufacturing Operations team. This position will support the engineering design, construction, and commissioning of a new phase I/II cGMP manufacturing facility and provide operational support of day-to-day manufacturing equipment, upon completion. The candidate will be responsible for the system ownership and project execution of process and utilities equipment.

 

The ideal candidate has experience in process engineering, utilities, and manufacturing equipment, supporting a drug manufacturing facility. This position requires engineering experience in the biotechnological, pharmaceutical, gene therapy, or a related field supporting process equipment. Specific experience in a variety of the following areas: utilities, cell cultivation, bioreactor operations, clarification, purification, or fill finish operations is preferred. The ideal candidate is creative, able to work individually and within a diverse team.

 

Essential Functions and Duties

 

ProjectSupport

  • Support engineering testing, commissioning and qualification activities
  • Responsible for process equipment designs by working with external supply partners
  • Assist in troubleshooting and remediating exceptions found during process startups and technology transfers
  • Accountable for all phases of the engineering lifecycle
  • Defines all aspects of project scope, manages project schedule, and coordinates project activities
  • Ensure all project documentation is accurate and up-to-date (P&lDs, mechanical system drawings, automation documentation, etc.)

Operational Support

  • Own process systems for GMP manufacturing
  • Work with a cross-functional group in developing requirements and recommendations for system/facility modifications
  • Owns and ensures timely closure of equipment corrective and preventative actions
  • Maintain equipment capabilities in alignment with process and end-user's needs
  • Responsible for troubleshooting activities, equipment design, and specifications for equipment (including single-use) and instrumentation.
  • Determine corrective maintenance actions and collaborates on preventative maintenance
  • Provide guidance to maintenance personnel and actively participates in the decision making and project execution of process and/or design improvement
  • Responsible for addressing safety related design/equipment issues
  • Collaborate with manufacturing personnel regularly about standard practices and procedures for process and utilities equipment/automation design and operation.
  • Provide technical input to manufacturing on SOP changes, deviations, GMP investigations and CAPAs
  • Interact routinely with process development, manufacturing, quality, facilities, and procurement to proactively address process and performance problems
  • Provide on-call support for all active process equipment

Documentation, StandardsandTemplates

  • Write, review and approve equipment specifications, engineering procedures and protocols
  • Assist in the revision of manufacturing documentation (SOPs, BR, etc.)
  • Actively manage engineering drawings coordinating and executing redlines and revisions

Skills and Experience

  • Requires a Bachelor's degree in Chemical/Mechanical Engineering or equivalent
  • Minimum 2-4 years of experience in a cGMP engineering environment
  • Experience in engineering, facility design, automation or related disciplines
  • Hands-on expertise with bioprocess engineering and knowledge of disposable applications in a biologics process, is preferred
  • Familiar with biotechnology single-use and stainless-steel process equipment
  • Effective verbal and written communication skills
  • Competent with domestic and international GMP regulations
  • Frequent use and general knowledge of industry practices, techniques, and standards
  • Able to accommodate rapidly changing priorities and deadlines
  • Must be a team player able to embrace a team-based culture
  • Demonstrates the ability to work independently to solve complex process and equipment problems
  • Capable of establishing working relationships with internal departments and external supply partners
  • Proficiency with Microsoft Office products and able to learn additional software applications, as needed

Interested candidates should forward a cover letter and Resume / CV to careers-AT-homologymedicines.com

 

www.homologymedicines.com

 

Homology Medicines, Inc. (HMI) has built foundational intellectual property on gene editing and gene therapy vectors derived from naturally occurring human adeno-associated viruses (AAVs). The Company's technology is precise, on-target and highly efficient for in vivo editing of genetic mutations. This transformative platform technology, combined with an elite leadership team of biopharmaceutical industry veterans, create a significant opportunity for HMI to rapidly advance a diverse pipeline of new medicines that address and potentially cure the underlying cause of genetic diseases.