Process Development Engineer II - CDMO - Massachusetts

Burlington Permanent USD70,000 - USD95,000
  • Process development for early phase drugs through small scale commercialization
  • Co-lead and contribute to development team execution of product development

About Our Client

Our client provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries. They are unique in their focus of providing process development for early phase drugs through small scale commercialization. As such their development personnel require an understanding of process development from both a scientific and engineering perspective. Candidates with either background can be successful and will be considered.

Job Description

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

Description

  • Process Engineering IIs / Process Scientists are expected to provide technical, quality and compliance leadership and mentorship of less experienced personnel within the department.
  • Tech transfer client product/process information with the goal of designing a manufacturing process to support GMP production of the client product.
  • Identify and specify process equipment and single use components needed for client tech transfer.
  • Co-lead and lead process development activities including process characterization at lab, pilot and full scale developing techniques and process parameters specific to the client's product while maintaining critical product attributes.
  • Perform lab and pilot processing operations (ENG and GMP) including equipment preparation, bulk product formulation, sterile filtration, and filling to facilitate process development and internal technology transfer.
  • Develop Engineering and GMP batch records for client-specific formulation and filling / finish operations.
  • Author instructions for the operation of equipment and process flows into the clean room facility.
  • Align with agreed upon client Scope of Work proposals containing standard statistical approaches (JMP software) for on-time report milestone delivery.
  • Lead the technical interface with the client via regular attendance at meetings with presentations and reports.
  • Participate in regularly scheduled project team meeting providing routine project updates identifying actions, prioritizations, risks and project needs.
  • Operate as an SME and author/investigator for GMP investigations; e.g., CAPA, deviations, and change requests. This includes closure reports for investigations that include Root Cause Analysis and CAPA planning / effectiveness actions as assigned to Process Engineering.
  • Operate and work within the Process Engineering Laboratory in a safe and compliant manner. Maintain equipment in clean, organized and well maintained state.
  • Adhere to site safety requirements and maintain an overall safety culture.
  • Understand and follow OSHA, HAZOP, and our procedures and guidelines when handling or disposing of hazardous materials.
  • Maintaining full compliance to defined department training requirements.
  • Will open Deviations and author/complete required procedural and Change Controls / CAPAs in process to the attention of the shift supervisor, Engineering Manager, and/or Quality Assurance to ensure timely quality system completion and closures and communication.

The Successful Applicant

  • B.S. in Scientific, Engineering, or related
  • 3+ years' experience in a cGMP/FDA regulated environment
  • U.S. employees must be fully vaccinated
  • Qualification in aseptic technique and familiarity with clean room personnel/equipment flows is desirable.
  • Knowledge of process flows; e.g., disposables strategies, filtration, mixing strategies, fluid transfer to and from various vessels/biobags.
  • Working knowledge of engineering processing aids such as sanitary connections, valves and pharmaceutical equipment and process design.
  • Computer literate with excellent working knowledge of spreadsheet software. Working knowledge of Visio or equivalent drawing programs a plus.
  • Experience with particle size reduction techniques, such as extrusion, microfluidization, or homogenization.
  • Experience with lyophilization processes and principles are also desirable.
  • Knowledge and understanding of the principles associated with aseptic filling technology (e.g. rotary piston/positive displacement pump, peristaltic pump systems).
  • Familiarity and understanding of cGMP's in a accordance with 21CFR210, and 21CFR211.
  • Experience leading and working in a fast-paced environment and success in cross-collaborative team dynamic.
  • Experience with CIP/SIP a plus.
  • Experience in executing the concepts within Quality Risk Management per ICH Q9 in support of process design, risk assessments and investigations.

What's on Offer

  • Join a talented workforce, where a commitment to excellence and a customer focused attitude is everything.
  • Work to improve patients' lives with the pharmaceuticals you develop and manufacture.
  • Great size: Small enough to remain agile and nimble, empowering you to make your mark in discernable ways as our organization evolves. Yet large enough to provide your work with the potential for global reach and impact.
  • Events that help teams to bond and become even better collaborators: After-hours get-togethers, lunch-and-learns, holiday parties, birthday celebrations and special themed events designed to brighten the workday.
  • Comprehensive total compensation package that aligns directly with business & individual results.
  • Benefits and perks designed to provide support, including health and wellness resources, insurance options, financial resources, and advantages for work, life and family.
Contact
Faith Emery
Quote job ref
JN-012022-4578490

Job summary

Sector
Life Sciences
Sub Sector
Biotechnology
Industry
Healthcare / Pharmaceutical
Location
Burlington
Contract Type
Permanent
Consultant name
Faith Emery
Job Reference
JN-012022-4578490