Sr. Project Engineering Manager
Company: Renaissance LLC
Location: Lakewood
Posted on: July 31, 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.OverviewThe Sr.
Project Engineering Manager will be responsible 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.This position will
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 required.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
experiencePI184258722
Keywords: Renaissance LLC, Lakewood , Sr. Project Engineering Manager, Executive , Lakewood, New Jersey
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