Critical Systems Engineer
Company: Renaissance Services
Location: Lakewood
Posted on: January 19, 2023
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Job Description:
Renaissance LLC
All qualified applicants will receive consideration for employment
without regard to race, color, sex, sexual orientation, gender
identity, religion, national origin, disability, veteran status,
age, marital status, pregnancy, genetic information, or other
legally protected status.
Overview
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 Renaissance organization goals.
--- Develop, and foster good working relationships with internal
and external stakeholders and support initiatives required to
continually enhance Renaissance's reputation.
Qualifications
Bachelor's degree in Engineering preferred along with experience
and a proven record of achievement on critical facilities systems.
A minimum of 3 years of relevant experience in the pharmaceutical
industry is required.
PI200402019
Keywords: Renaissance Services, Lakewood , Critical Systems Engineer, Professions , Lakewood, New Jersey
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