Engineering Manager (Pharmaceutical I...
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Jan
25
Sandeep Singh Dhillon
Engineering Manager (Pharmaceutical Industry) at Germer International Buffalo, NY (Monster.com)
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About the Job

Germer International’s client, a $6B Pharmaceutical organization already recognized as one of the top three pharmaceutical companies manufacturing generic controlled substance sterile injectable products here in the US, is actively looking to expand their engineering team. Due to major growth of their organization, they are greatly expanding their state-of-the-art facility and need qualified Pharmaceutical Engineers who understand sterile operations to come aboard and join their team. They are actively looking foran Engineering Manager who will be responsible for managing the engineering team as well as engineering functions including plant engineering, project management, and computer aided drawing and design. The team will comprise of Manufacturing and Project Engineers, CAD personnel, Technical Writers, Mechanics/Electricians, and Administrative staff who will work together to improve plant quality, operational efficiency/effectiveness, capacity, capability, and modernization objectives.

Responsibilities:

Responsible for the design, procurement, installation, and improvement of site manufacturing and utility equipment as well as facility upgrades and expansions in a cGMP environment.
Responsible for the design, fabrication/construction, and implementation of upgrades to existing and/or new facilities, utilities, and equipment.
Manage projects such as the design and installation of new or upgraded manufacturing lines and utility systems.
Manage the startup of new processes and technologies such as lyophilization, clean in place (CIP) / sterilize in place (SIP), water systems, waste systems, and utility systems.
Manage the design and construction of new and renovated facilities.
Manage departmental and capital budgets.
Manage day to day engineering support functions such as project development and drawing updates/requests.
Assist maintenance and operations in problem solving and process improvements.
Maintain cGMP, OSHA, and DEC compliance through implementation and adherence to SOP’s and governmental regulations.
Initiate, author, review, and approve change control, specifications, risk assessments, work orders, standard operating procedures (SOPs), capital project approvals (CPAs), purchase requisitions/orders, factory/site acceptance tests (FAT/SAT), corrective actions, and associated interim/final reports and other paperwork in compliance with Company policy.
Manage the preparation and approval of validation protocols for new and upgraded equipment, facilities, and utilities.
Review final documentation packages for all major systems at the plant including, but not limited to utility systems, filling operations, packaging operations, dry heat sterilization/depyrogenation, steam sterilizers and process washers.
Participate in and resolve audit and regulatory deficiencies.
Serve as reviewer and approver for deviation investigations
Hire, develop, organize and lead staff.
Establish and implement appropriate engineering staff training requirements.
Requirements:

BS in an Engineering/technical discipline required, masters preferred. MBA a plus.
Minimum of 5 years of experience in an engineering and/or cGMP manufacturing environment, preferably a pharmaceutical environment
Knowledge of all aspects of manufacturing processes, automation and controls such as PLCs and HMIs, machine design and layout, utilities and piping including compressed air and gasses, steam and water systems, HVAC, fire protection, project management, Autocad, construction, drawing standards including the ability to read and decipher drawings including process and instrumentation (P&ID), and general supervision.

Please visit https://job-openings.monster.com/Engineering-Manager-Pharmaceutical-Industry-Buffalo-NY-US-Germer-International/11/192647339 to apply



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