Process Engineer III in Burlington, MA at AMRI

Date Posted: 8/11/2019

Job Snapshot

Job Description

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

Job 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

Albany Molecular Research, Inc. is committed to providing equal opportunity to all job seekers including qualified individuals with disabilities. If you have any difficulty using our online application system due to a disability or believe you need a reasonable accommodation to search for a job opening or submit an application, you may use the alternative email address "jobs@amriglobal.com" to contact us about your interest in employment or you may call us at 518.512.2000.

Please note: The above-referred email address and telephone number are dedicated communication lines designed exclusively to assist job seekers whose disability prevents them from being able to apply online. Messages left for other purposes will not receive a response.

AMRI is committed to providing equal opportunity to all job seekers including qualified individuals with disabilities. If you have any difficulty using our online application system due to a disability or believe you need a reasonable accommodation to search for a job opening or submit an application, you may use the alternative email address jobs@amriglobal.com to contact us about your interest in employment or you may call us at 518.512.2000.

Please note: The above referenced email address and telephone number are dedicated communication lines designed exclusively to assist job seekers whose disability prevents them from being able to apply online. Messages left for other purposes will not receive a response.