Engineering / Facilities

Facilities Engineer (II, III, or Sr.) - Biologics Process Equipment Direct Hire MA

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Job ID: 14878 Direct Hire MA

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Our client is a global biopharmaceutical giant with dozens of approved products on market and a biologics campus located in the suburbs of Boston.  They are seeking experienced Engineers to join their Facilities Engineering Group and lead the engineering support efforts for various manufacturing, maintenance, and capital projects for Upstream Process Equipment, Downstream Process Equipment, Critical Utilities, etc.  Approximately 50% of time will be focused on "on-the-floor" activities and half on Capital Projects and/or Continuous Improvement.  

Responsibilities include but are not limited to;
•  Identification of a new/revised equipment and/or critical utility
•  Design/installation/verification/validation of the equipment and/or critical utility
•  Maintenance of the equipment and/or critical utility in its commissioned and validated state, and retirement when appropriate
•  Analyze and present interpretation of results for operational issues and/or concurrent engineering projects 

QUALIFICATIONS:
 
• Hiring Manager is open to all education levels (BS, MS or PhD) in Mechanical, Electrical or Chemical Engineering and several years of industry GMP experience and can title the position based on level of experience (Level II, III, or Senior Engineer).
• Working knowledge of biopharmaceutical processes, and associated bioprocess equipment is preferred.  The Hiring Manager can consider those with without biologics experience if they have strong GMP experience.
• Direct experience in highly-regulated environments (cGMP, OSHA, EPA).
• General understanding of Quality Systems, Commissioning, Qualification, and Validation.

Formal descriptions can be supplied for interested candidates.
 
Must be authorized to work in the US indefinitely to be considered.  All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.
 

Automation Engineer Direct Hire MA

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Job ID: 14867 Direct Hire

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cGMP Biologics company here in Central Massachusetts is looking to add Automation Engineers to their team!  These roles will ensure reliable operation and implementation of all automation systems for a 24x7 commercial manufacturing facility. Projects may often require independent decision making and exercising of judgment. Project work is generally prioritized by the group manager or lead engineers.  In addition, other responsibilities include by not limited to: 

  • Support the configuration, administration and maintenance activities of the site’s manufacturing computer and automation systems, including process control systems, building automation systems, manufacturing execution systems, and data historians.
  • Lead projects in the design, development, and qualification of automated processes, equipment, and systems; including managing the work of internal engineers and outside vendors.
  • Identify opportunities to improve existing process, equipment, systems, and infrastructure.
  • Directly support operations with troubleshooting and issue resolution with respect to computer and automation systems.
  • Lead small cross functional teams in support of small projects or initiatives.
  • Be part of on-call rotation for off-hours manufacturing support (remote, every 5-7 weeks).

Requirements:

  • Bachelor's degree with at least 3+ years of DeltaV experience within a GMP manufacturing environment.  Title/Level DOE.
  • Experience with some of the following platforms is a plus: Allen Bradley PLC, OSI Soft PI historian, Instrumentation and control panel hardware. 
  • Experience with computer systems validation practices (GAMP).

Associate Director, Global EH&S Direct Hire MA

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Job ID: 14712 Direct Hire MA

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Global Biologics Pharmaceutical Company looking for an Associate Director, EH&S to join their team!  Although the Company is headquartered in MA, position may be located in MA, IL, CA, Dublin, Ireland, Neuchâtel, Switzerland or Vienna, Austria.  This role is responsible for the providing Global support to the High Hazard Management Program, (HHMP) internationally and for a variety of different sites and plants. This individual will serve as the primary contact for Process Safety in the EHS-HHMP space and will be responsible for deployment of enhanced emergency response processes across the enterprise. In addition, the role will support audit and assessment programs and other existing enterprise EHS programs that fall into the HHM areas of expertise. Other responsibilities include but not limited to:

  • Lead the High Hazard Management Program (HHMP), identifying key EHS risks and developing/managing the implementation of company-wide control programs;
  • Develop Corporate Standard Operating Procedures to assist facilities in addressing the “operational controls” component of the HHMP. Manage routine updating and revision of existing procedures;
  • Using Stature Risk Assessment software, generate and manage HHMP metrics and milestones to provide effective visibility to senior management of the program status, with individual facilities and significant aspects highlighted for attention;
  • Generate hazard specific training materials to assist facilities in addressing the “training” component of the HHMP. Deploy these materials across the business unit in a standardized fashion;
  • Act as the primary point-of contact for the organizations Process Safety Program, developing, implementing and monitoring programs to effectively manage process related hazards/risks;
  • Perform facility and program specific audits to identify compliance/requirements gaps and opportunities for improvement. Assist facility EHS staff in generation of effective CAPAs. Provide guidance and oversight of implementation and closure of CAPA plans;
  • Support to the Head of Biologics EHS in the development and implementation of organizational wide Safety Programs;
  • Provide leadership and direction for internal safety resources to ensure collaboration and sharing of best practices on policies, programs and procedures;
  • Drive prevention and risk reduction programs to improve safety and health programs, policies and procedures; provide technical training and awareness of industry practices and changes relating to health and safety;
  • Support the organizations incident management process; assisting/leading serious incident investigations, supporting sites in identification of root causes, the development of corrective and preventative actions and the sharing of lessons learned;

Requirements:

  • 10+ years experience managing EH&S programs at site, regional and/or organizational level.
  • Extensive experience in High-Hazard Safety Management, especially in the area of Process Safety, with detailed knowledge of PSM and ATEX requirements in US, Europe and Global facilities;
  • Experience of working with a global organization with an understanding of local and global laws, regulations and requirements for EH&S;
  • B.S. Degree in Environmental, Safety or related field.

*Estimated >25% domestic and international travel with increased travel during major projects.