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Process Engineer II in Burlington, MA at AMRI

Date Posted: 5/9/2019

Job Snapshot

Job Description



PROCESS ENGINEER II in Burlington, MA

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

The Process Engineer II 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:                                                                                 


  • 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
  • Develop batch records for client-specific formulation and filling / finish operations
  • 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. An Engineer level II will be required to undertake more independent, direct client interaction
  • 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 
  • Develop new manufacturing and aseptic filling processes to meet client requirements.  Ability to troubleshoot, amend and accommodate the process of aseptic formulation and fill of drug product such that it harmonizes with AMRI Manufacturing Facility while protecting the integrity of client technology / product.
  • Understands and follows OSHA, HAZOP, and AMRI procedures and guidelines when handling or disposing of hazardous materials and maintaining overall safety culture

Job Requirements

Qualifications and background to be successful in this role:

Required

  • Bachelor’s degree in Scientific Engineering or related field
  • 5 Years’ experience in a pharmaceutical development role, or related field

 

Preferred

  • Meticulous and highly organized.
  • Aseptic technique, familiarity with clean room personnel 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 CIP/SIP a plus.
  • Hands on experience is preferred

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.