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Stay current with the latest regulatory guidance and industry best practice in the area of practice such as but not limited to HVAC/Refrigeration/Containment/Chillers/Compressed Gasses/Steam.

Be able to support projects through all phases of execution including front end planning efforts and direct the development of detailed process description narratives, process flow diagrams, and P&IDs in these mechanical systems.

Have the Ability to direct and advise on the lay-out of these mechanical systems in manufacturing sites and to review equipment providers and making recommendations and selections based on project requirements.

Attend and/or coordinate factory acceptance tests and/or site acceptance tests for equipment.

Able able to develop and present continuing education topics internally.

Requirements

Degree in Mechanical Engineering with 10 plus years of relevant experience required.

Expert in developing process strategies/philosophies for Mechanical engineering projects such as but not limited to HVAC/Refrigeration/Containment/Chillers/Compressed Gasses/Steam.

Experienced in FDA, EMA, cGMPs and other regulatory standards and requirements for mechanical processes.

Advanced knowledge and application of cGMP as ISPE guidelines in mechanical applications.

Ability to present process designs to project and site clients, to author standards and to direct mechanical system design activities

Strong interpersonal and communication skills with demonstrated ability to work within a team environment

Qualifications

Masters Degree , Mechanical qualification , Bacheloru2019s degree in engineering , Bacheloru2019s in engineering

Skills

Project management
Manufacturing
People Management
Management Skills
Project Planning
Analytical Skills
Leadership Skills
Problem-Solving Skills

Experience

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