Critical Systems Engineer
Company: Renaissance LLC
Location: Lakewood
Posted on: January 22, 2023
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Job Description:
Renaissance LLCAll 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.OverviewThis
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.ResponsibilitiesTechnical---
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
projectsCommunications --- 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.QualificationsBachelor'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.PI200403655
Keywords: Renaissance LLC, Lakewood , Critical Systems Engineer, Professions , Lakewood, New Jersey
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