Critical Systems Engineer

9/27/22

Toms River, NJ

1817

This position is responsible for supporting the day-to-day operations of a cGMP manufacturing facility. The individual will support knowledge transfer to in house mechanics during installation, maintenance, and troubleshooting facility related equipment to ensure reliable operation. The individual should have good working knowledge of building management systems and be able to leverage that information to diagnose and rectify issues with class A-D clean rooms and utility systems. The individual will be tasked with reviewing and approving P&IDs and submittals for new construction and acting as an advisor/mentor to facilities mechanics to resolve technical problems.


This role will frequently interact with suppliers and contractors to improve building, equipment, and processes around the plant. The incumbent interfaces with internal and external stakeholders, Regulatory Compliance, QA, Operations, Planning and Regulatory Agencies (i.e. FDA & EMA). This role provides technical support to the entire engineering group and cross-functional teams, as needed.
Intimate knowledge of utility systems such as WFI water systems, Clean Compressed Air, and HVAC systems is a requirement for this role.

Responsibilities:

Technical

  • Ensure the appropriate maintenance and sustainability of all critical utilities such as Electrical Systems, WFI and USP Water Systems, Compressed Air System, HVAC Systems, including Boilers and Clean Steam Generators.
  • Demonstrate a strong understanding of HVAC, mechanical, and electrical systems, and be able to troubleshoot as necessary
  • Liaison with cross-functional stakeholders to solve specific operating problems and improve Facilities and Critical Utilities maintenance performance.
  • Provide recommendation and input on technical procedures, techniques and equipment performance.
  • Perform future need forecast through asset life expectancy management and closely monitor building infrastructure to ensure long term sustainability and successful growth of the organization.
  • Support the installation, start up, commissioning, qualification, and maintenance of facilities equipment, systems, and utilities associated with cGMP manufacturing, office space, laboratories, and warehouse
  • Responsible for investigations, deviations, and CAPA resolution implementation
  • Participate in planning, design, budgeting, scheduling, and execution of small projects

Communications

  • Represent the department in interactions with cross-functional stakeholders.
  • Interface and coordinate with cross-functional team members to successfully achieve the Engineering department’s goal and the overall company organization goals.
  • Develop, and foster good working relationships with internal and external stakeholders and support initiatives required to continually enhance the company’s reputation.

Qualifications:

  • Bachelor’s degree in Engineering required along with experience and a proven record of achievement on critical facilities systems.
  • 3+ years of relevant experience in the pharmaceutical industry is required.
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