Lead Mechanical Engineer
Millipore Corporation

Work Location: Indianapolis, Indiana
Shift: No
Department: LS-LS-AEN SAC Indianapolis Engineering
Recruiter: Leah S Westley

This information is for internals only. Please do not share outside of the organization.

Your Role:

Responsible for executing business unit driven equipment improvement and capital projects using practical application of fundamental engineering principles in a cGMP setting associated with sterile injectable products. Responsible for providing key engineering/technical support and project coordination as well as mentoring junior engineers. Responsible for interfacing with internal and external clients in support of equipment projects, manufacturing of pharmaceutical products, and investigations.

This specific role will be the system owner for filling and lyo equipment. This role will have input and oversight on equipment process changes, improvements, new client transfer, and investigations from an equipment standpoint.

Major Position Activities & Responsibilities:

• Provide technical support for the manufacturing equipment, including investigations, continuous process improvements, change controls, and client onboarding.
• Mentor junior engineers in execution of their responsibilities
• Coordinate and execute small to medium scale and/or complex technical projects. Associated functions include process and equipment design engineering, project estimating and budgeting, developing capital appropriation requests, documentation updates, scheduling and overall project coordination and oversight. Project staffing will be comprised of personnel from various departments on-site, as well as contract personnel. Individual will be required to coordinate multiple projects of varying scope and size concurrently.
• Provide engineering leadership for technical projects. Associated tasks include equipment specification and procurement, process development, drawing development, protocol development, validation input, and execution.
• Interpret, modify and create engineering drawings, including Piping and Instrumentation Diagrams, Piping Drawings, Layouts, Isometrics, Building Mechanical, Instrumentation and Electrical Drawings.
• Creation of Standard Operating Procedures (SOPs) for new equipment/processes, as well as update of existing SOPs.
• Perform process and utility calculations as related to hydraulic design, heat transfer, material balances, etc.
• Lead and provide technical support for technical investigations.
• Performs special projects and other duties as assigned.

Scope:

• Responsible for support of all types of facility projects. Project reporting is a dotted line structure with respect to specific project responsibilities only.

Who you are:

Minimum Qualifications:

• B.S. / M.S. in Chemical Engineering, Electrical Engineering, Mechanical Engineering or related field
• Ten (10) or more year's minimum experience in GMP or regulated operations as validation engineer, process engineer, project engineer, or similar capacity. Previous experience coordinating projects and personnel is required.

Preferred Qualificaitons:

• In-depth knowledge of US and European GMP requirements, FDA guidelines, and industry validation expectations is required.
• In-depth knowledge of aseptic manufacturing processes and packaging equipment, fill/finish operations, process unit operations, process control systems, computer systems, equipment cleaning, sterility assurance, process hazards and safety.
• Prior experience with RABS filling, Isolator filling, and lyophilization is preferred
• Strong hands-on skills are desirable
• Special Training:
  • Advanced PC skills with spreadsheets, word processing and databases
  • Knowledge of Microsoft Project or similar project scheduling software
  • Previous training in project management skills, Kepner-Tregoe or another program
  • Knowledge of Root Cause Analysis methodology, FMEA or another program
  • Knowledge of Microsoft Visio, AutoCAD, or similar drawing program
  • Knowledge of Minitab, Jump, or similar statistical software
• Personal Skills:
  Employee must be self-motivated, highly organized, and conscientious. Effective interpersonal skills are required to interface with internal and external clients as well as outside contractors. Must be able to work and make decisions independently as well as with a team. Must be able to work in technically and mentally demanding situations. Strong verbal and written communications skills are required. Must be well organized to effectively coordinate multiple projects concurrently. Strong mediation skills are essential in gaining and maintaining cross-departmental project support.
• Employee must be available to work hours outside of the standard operating shift on occasion as required to maintain the production schedule.
• Physical Requirements:
  Employee must have sufficient mobility to work in a process environment. The employee will be required to climb stairs and ladders to perform the functions of this job.

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

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