Sr. Project Engineering Manager
Company: Renaissance LLC
Location: Lakewood
Posted on: June 24, 2022
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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.OverviewResponsible
for providing Engineering leadership in a CDMO organization.
Develop and implement technical solutions to support both
development and commercial client needs, while ensuring design for
manufacturability and successful design transfer.Introduce
technology and equipment/processes that will enhance the efficiency
and effectiveness of the Renaissance operations. Manage small- and
large-scale projects from concept through implementation,
coordinating activities of the various support functions (MS&T,
Validations, Quality, Operations, Clients) to ensure successful
implementation (commissioning and validation) on time, and on
budget. Participate as a member of the Senior Management Team in
developing site strategies and policies and represent Renaissance
with customers and regulatory agencies.Responsibilities--- Define
and develop processes to ensure robust equipment start up for
successful commercialization. Partner with clients and development
teams to ensure design for manufacturability for all parts of the
manufacturing process (compounding, filling, assembly, final
packaging, serialization, etc)--- Manage small-to-large size
projects related to process equipment, automation, and
manufacturing.--- Assist in the design review, site acceptance, and
installation of equipment.--- Collaboration and coordinate
activities across operations, MS&T, validations, development,
maintenance, facilities, quality as well as external contractors to
ensure successful project implementation. --- Prepare necessary
documentation to support engineering projects including project
scopes, presentation of conceptual designs, capital requests,
specifications, piping and instrumentation diagrams, process flow
diagrams, schedules, requests for quotations, project expenditures,
project procedure, correspondence, start-up procedures and cost
estimates.--- Support QA and Validation departments by preparation
of design documents, user requirements specifications, and
assisting in protocol generation and execution.--- Implements
connective/preventive actions for existing equipment and
manufacturing processes.--- Prepare change control
documentation.--- Review and modify procedures for the proper
operation of new and/or existing equipment.--- Ensure safety
requirements and risks are proactively addressed. --- Research and
purchase new manufacturing technology and environmentally friendly
practices into existing processes. --- Ensure projects are
completed on time and financial budgets achieved.--- Develop a high
performing team through mentoring, coaching, training and
development of employees that fosters employee growth. --- Perform
other duties and responsibilities as assigned.QualificationsB.S.
degree in Mechanical, Chemical or Electrical Engineering is
required. A minimum of five (5) years of relevant experience in the
pharmaceutical industry is preferred.Must possess: --- A thorough
knowledge of cGMPs and sanitary equipment design requirements---
Advanced knowledge of engineering documentation required for cGMP
process equipment; and Preferred Experience:--- CDMO experience---
Aseptic processing experiencePI183045842
Keywords: Renaissance LLC, Lakewood , Sr. Project Engineering Manager, Executive , Lakewood, New Jersey
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