Sr. Project Engineering Manager
Company: Renaissance Services
Posted on: November 18, 2022
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.
The 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.
--- 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
--- Collaboration and coordinate activities across operations,
MS&T, validations, development, maintenance, facilities,
quality as well as external contractors to ensure successful
--- 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
--- Research and purchase new manufacturing technology and
environmentally friendly practices into existing processes.
--- Ensure projects are completed on time and financial budgets
--- Develop a high performing team through mentoring, coaching,
training and development of employees that fosters employee
--- Perform other duties and responsibilities as assigned.
B.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.
--- A thorough knowledge of cGMPs and sanitary equipment design
--- Advanced knowledge of engineering documentation required for
cGMP process equipment; and
--- CDMO experience
--- Aseptic processing experience
Keywords: Renaissance Services, Lakewood , Sr. Project Engineering Manager, Executive , Lakewood, New Jersey
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