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Process Engineer III

AMRI Burlington Full-Time
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Process Engineer III in Burlington, MA

 

AMRI provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.

 

The Process Engineer III will be responsible for facilitating the tech transfer of client processes and executing engineering functions including design and document controls. This individual will also be expected to contribute toward continuous improvement initiatives in support of overall operational efficiencies and improved compliance.

Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture.

In this role, you will:

 

  • Develop batch records for client-specific formulation and filling / finish operations
  • Perform processing operations (ENG and GMP) including equipment preparation, bulk product formulation, sterile filtration, and filling support to facilitate process design and internal technology transfer
  • Operate as an SME for GMP investigations (e.g. CAPA, departures, CCRs) as well as finalize closure reports for departures which are assigned to Process Engineering
  • Direct client interaction, summarizing engineering-related work completed verbally as well as written
  • Identify and specify process specific equipment needed for client tech transfer, developing techniques and process parameters specific to the clients’ product while maintaining critical product attributes
  • Author instructions for the operation of equipment and for detailing process flows in clean room facility
  • Develop new manufacturing and aseptic filling processes to meet client requirements

Qualifications and background to be successful in this role:

 

Required:


•         Bachelors of Science degree in Scientific, Engineering, or related field required

•         7+ years’ experience in a cGMP/FDA regulated environment is preferred

•         Advanced degree in related field may be considered in lieu of experience

  • Aseptic technique, 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 process engineering processing aids such as sanitary connections, valves and pharmaceutical process design
  • Experience with particle size reduction techniques, such as extrusion, microfluidization, or homogenization
  • Experience with lyophilization principles
  • Familiarity and understanding of cGMP’s in a accordance with 21CFR210, and 21CFR211
  • Knowledge and understanding of the principles associated with aseptic filling technology (e.g. rotary piston/positive displacement pump, peristaltic pump systems)
  • Experienced in practicing Quality Risk Management per ICH Q9

Preferred:

  • Hands on experience is preferred
  • Experience with CIP/SIP a plus
  • Computer literate with good working knowledge of data analysis and design software (Minitab, JMP, Solidworks, VISIO) a plus

All interested applicants must apply online.  AMRI is an Equal Opportunity Employer, we value diversity and inclusiveness.  Minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity are encouraged to apply.



Shift:  Standard 8

Skills required

Quality Assurance
Resolve Technical Issue
Testing
Provide Technical Guidance
Mechanical Engineering
Engineering Design Process

Location

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$110K
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Process Engineer III
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Job ID: 1002762

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Albany Molecular Research, Inc. (AMRI) is a global contract research and manufacturing organization with more than twenty years’ experience in providing customers with fully integrated drug discovery, development, and manufacturing partnerships. AMRI builds its expert knowledge and advice into customers’ programs to deliver a complete range of value-added services with more informed decision-making, resulting in enhanced efficiency and more successful outcomes at all stages of the pipeline. AMRI’s smarter options for insourcing and outsourcing support discovery and development of pharmaceutical products, manufacturing of API and drug product for existing and experimental new drugs. With unrivalled project management and locations in the United States, Europe, and Asia, AMRI maintains geographic proximity and seamless delivery across multiple sites. AMRI has historically leveraged its drug discovery expertise to progress several internal programs to the development candidate stage and, in some cases, into Phase I clinical development. AMRI has successfully partnered certain programs and is actively seeking to out-license its remaining programs to strategic partners for further development.

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