Engineering / Facilities

Associate Director, Global Calibration Programs Direct Hire MA

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Job ID: 14742 Direct Hire MA

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Global Pharmaceutical company is growing their Maintenance Engineering team!  They are looking to add an Associate Director, Global Calibration Programs to their team!  This role will lead the global calibration programs and projects and be the technical and compliance subject matter expert in instrumentation and calibration.  Will be Responsible for development, implementation and on-going support of programs, processes, and procedures to ensure business and compliance objectives are met.  Other Responsibilities include: 

  • Provides operational direction for calibration program. Document owner for global calibration procedures.
  • Subject matter and compliance expert for instrumentation and calibration topics.
  • Business owner for calibration computerized maintenance management systems.
  • Leads development and standardization of the global calibration program with focus on increased harmonization, efficiency and compliance.
  • Collaborates with stakeholders to optimize the calibration program and to resolve maintenance related inspection observations with global implications.

Requirements:

  • 8+  years of industry experience in both instrumentation and calibration in a GMP environment plus experience in managing GMP calibration programs with indirect people management. 
  • Desired: Bachelor’s Degree in an engineering related field and/or significant military service experience in this field.

Note:  This role may sit at one of their Tech Ops locations either in MA, CA, GA or IL.  As well as International sites in Dublin, Ireland, Rieti, Italy, Singapore, Switzerland, Vienna, Austria or Lessines, Belgium

Associate Director, Global Maintenance & Shutdown Direct Hire MA

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Job ID: 14741 Direct Hire MA

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Global Pharmaceutical company is growing their Maintenance Engineering team!  They are looking to add an Associate Director, Maintenance & Shutdown to their team!  This role will lead global maintenance programs and projects and the subject matter and compliance expert in maintenance and maintenance shutdown management. Responsible for development, implementation and on-going support of programs, processes, and procedures to ensure business and compliance objectives are met.  Other responsibilities include: 

  • Provides operational direction for maintenance systems and programs.
  • Document owner for global maintenance and plant shutdown procedures.
  • Subject matter and compliance expert for maintenance topics.
  • Global process owner role for maintenance quality systems.
  • Leads development and standardization of the global maintenance program with focus on increased harmonization, efficiency and compliance.
  • Collaborates with stakeholders to optimize the maintenance program and to resolve maintenance related inspection observations with global implications.
  • Provides leadership and subject matter expertise for optimization and management of plant shutdowns.

Requirements:

  • Bachelor’s Degree with 8+  years’ experience managing engineering or maintenance activities in a GMP manufacturing environment (preferably Life Science Industry).

Note:  This role may sit at one of their Tech Ops locations either in MA, CA, GA or IL.  As well as International sites in Dublin, Ireland, Rieti, Italy, Singapore, Switzerland, Vienna, Austria or Lessines, Belgium

Associate Director, Global Maintenance Systems Direct Hire MA

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Job ID: 14740 Direct Hire MA

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Global Pharmaceutical company is growing their Maintenance Engineering team!  They are looking to add an Associate Director, Global Maintenance Systems!  This role will act as the business owner for global maintenance management systems and the subject matter expert in computerized maintenance management systems, processes, and procedures. Responsible for development, implementation and on-going support of maintenance programs, processes, and procedures to ensure business and compliance objectives are met.  Other Responsibilities include:

  • Provides operational direction for maintenance systems and programs. Document owner for global maintenance procedures. Subject matter expert for maintenance program topics. Business owner for global computerized maintenance management systems.
  • Leads development and standardization of the global maintenance program with focus on increased harmonization, efficiency and compliance. Collaborates with stakeholders to optimize the maintenance program and to resolve maintenance related inspection observations with global implications.
  • Leads global maintenance teams.
  • Fosters environment for knowledge sharing and development within the engineering organization. Identifies best practices, promotes sharing and adopting, and incorporates into global standards as appropriate. Leads continuous improvement efforts for global maintenance systems and processes.
  • Effectively collaborates with customers to understand issues and opportunities and partners with them to drive improvements.
  • Key collaboration with Information Technology group to ensure CMMS provides appropriate functionality and performance to user community in an efficient and compliant manner.

Requirements:

  • Bachelor’s Degree, 8+ years’ experience in a highly regulated GMP industry, with progressively larger and more complex scopes of responsibility.
  • Experience managing an enterprise-wide computerized maintenance management systems in a GMP environment (preferably Life Sciences).

Note:  This role may sit at one of their Tech Ops locations either in MA, CA, GA or IL.  As well as International sites in Dublin, Ireland, Rieti, Italy, Singapore, Switzerland, Vienna, Austria or Lessines, Belgium

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.

Head of Environmental Health and Safety Direct Hire MA

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Job ID: 14607 Direct Hire MA

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EH&S leadership opportunity at one of the state's top biopharma campuses, producing commercial and clinical biologics.  

The main function of this role is to direct the implementation of a comprehensive EHS program for process development, manufacturing, research, and warehouse operations at a multiple sites in the suburbs of Boston.  Functioning as a member of the site’s leadership team, you will work closely with peers to build a culture of EHS excellence at the site. 

Responsibilities include but are not limited to;
•  Develop strategic plans for continuous improvement in EHS performance and provide leadership as the management representative for EHS including influencing and directing employees at all levels of the organization to achieve excellence in EHS. 
•  Support business growth via management of permit revisions and new regulatory requirements; assess new projects/processes for impact on same and health & safety of employees. 
•  Define, maintain and manage the site emergency response procedures to assure preparedness and organized management of crisis situations. 
•  Champion and support resource conservation initiatives in cooperation with facilities and engineering. 
•  Direct and support the work of the EHS professionals at the site and develop a high performing team culture for the EHS department.  

Formal descriptions can be supplied for interested candidates. 

Qualified candidates will have a BS in a technical discipline and 10-15+ years’ experience in a EHS related field. Must be knowledgeable in US EPA, OSHA and DOT regulations, must be experienced with ISO 14001 and OHSAS 18001 management systems. Experience in pharmaceutical manufacturing or other high hazard industry (oil & gas, pulp & paper, chemical manufacturing, steel, etc). 

Must be authorized to work in the US indefinitely to be considered and must be commutable to the Greater Boston area.  Relocation assistance available for qualified candidates.   

All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.

Sr. Automation Engineer Direct Hire Massachusetts

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Job ID: 14600 Direct Hire Massachusetts

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Global cGMP Biologics company here in MA is looking to add a Sr. Automation Engineer to their Cambridge Area team!  This role 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 sites 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 processes, 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.
  • May have technical leadership or supervisory responsibilities over more junior engineers.

Requirements:

  • Bachelor's degree AND 8+ years of relevant work experience OR Masters with 5+ years. 
  • Experience with some of the following platforms: DeltaV, Allen Bradley PLC, OSI Soft PI historian, Instrumentation and control panel hardware. 
  • Experience with computer systems validation practices (GAMP).
  • Experience authoring and reviewing standard operating procedures, on-the-job-trainings, and other controlled documents.