Process Engineer

POSTED: August 9, 2018
BUSINESS: Purdue GMP Center
POSITION TYPE: Full-time 
START DATE: Immediate Availability

Overview:

Process Engineer will work collaboratively and proactively with Facility & Engineering staff and other functional staff to manage equipment, services, and processes that support the core business of Purdue GMP Center; provide support in the planning and execution of capital investment projects; advise on and execute development and/or manufacturing projects for clients; make sure the organization has the most suitable working environment for its employees and their activities; apply best practices to improve efficiency and reduce operating cost, is responsible for planning strategic and day-to-day operations involving building and process equipment; and adhere to all security, safety, and regulatory requirements.

Specific Duties and Responsibilities:

  • Assist in the management of process equipment, facility systems, infrastructure, and onsite contractors to ensure that all the equipment and facilities are working properly at all times.
  • Manage and organize all aspects of PGC’s Facilites & Engineering to meet industry standards and best practicies, as well as regulatory guidance for pharmaceutical manufacturing.
  • Lead, train, and coach Facilities & Engineering staff and other fuctional staff, as neeeded.  Develop and maintain the highest standards for internal and external customer satisfaction.  Cross train staff for efficient operation of all equipment and facilities.  Facilitates open communication and problem solving.
  • Provide recommendations on equipment, processes, and facility systems for capital investment.
  • Lead project engineering for new site projects.  For site-based projects, such effort may include project and construction management.  For large projects [generally those involving a third party engineering contractor], such effort may include design guidance, review and approval, and liaison with site functions, as site engineering representative.
  • Develop and maintain engineering procedures and documentation for manufacturing, facilities, utilities, and new projects to ensure effective and compliant execution of engineering work on site.
  • Support major equipment/systems implementation and maintenance, repair and/or replacement.  Establish standards, provide reports and follow up benchmarking, to analyze equipment, manage service contracts and review expense budgets.
  • Advise and execute development and/or manufacturing processes for clients.
  • Maintains support system, performance of design specification, equipment calibration, preventative maintenance, and ensures validations of facility and equipment are completed timely and within required guidelines.
  • Support investigation into all compliance related issues including Corrective Action / Preventative Action plans (CAPAs), deviations, periodic reviews and change controls.
  • Performs and coordinates response to emergency calls for related facility and equipment problems.
  • Develop proposals to resolve site issues and/or meet site opportunities.
  • Execute engineering investigations into performance of site manufacturing, facilities and utilities systems, and development of proposals to optimize performance.  These investigations can either be carried out internally, or by contractors.
  • Investigate site requirements to meet business opportunities, regulatory requirements and the like.  These investigations can either be carried out internally, or by contractors.
  • Interact comfortably and effectively with internal and external customers, supervisor, senior business leaders, service providers, and business partners, as needed.
  • Participate in audits by local, state, federal and international regulatory authorities including Indiana Department of Environmental Protection, Food & Drug Administration (FDA) and other agencies.
  • Follow all applicable state and federal laws regarding the operation of a cGMP facility.
  • Other duties as assigned.

Skills:

  • Excellent organizational skills and ability to handle successfully multiple projects / assignments.
  • Excellent verbal and written communication skills in:  one-on-one settings; small groups; and more formal settings.
  • Superior attention to details.
  • Ability to use good judgment, diplomacy, maintain confidentiality, and exercise discretion on various operational matters and customer service.
  • Ability to analyze and resolve complex problems using fundamental engineering and / or scientific principles.
  • Ability to apply engineering and / or scientific principles to develop procedures, specifications and standards for systems and equipment new to the site.
  • Working knowledge of solid oral dose manufacturing equipment, HVAC and utility systems, including building automation / management systems, and other engineering aspects of pharmaceutical manufacturing facilities.
  • Demonstrated computer skills, including the use of Microsoft Word, Excel, and PowerPoint.

Education/Experience:

  • Bachelor’s degree or equivalent and 7+ years of previous facilities and engineering experience.
  • Minimum 2+ years of supervisory and / or project leadership experience.
  • Industry experience in GMP bio/pharmaceutical manufacturing operations is required.  Ideal candidate will also have experience:
    • Working with equipment vendors and regulatory agencies.
    • Management of capital projects and budgets.
    • Writing and executing protocols for utilities engineering, utilities validation, process equipment qualification, and cleaning validations.  CIP/SIP (clean & steam in place) experience in clean and ‘dirty’ utilities.  Guide execution of protocols, procedures, utilities engineering & validation protocols. 

Requirements:

  • Favorable security (DEA/FBI/criminal) check and negative controlled substance test
  • Regular attendance is a requirement of this position
  • Ability to travel (5%), including vendor diligence and factory acceptance testing (FAT)

Physical Demands & Environmental Conditions:

  • Regularly walks, stands, and sits
  • Ability to drive routinely
  • Frequently lifts, pushes/pulls, climbs, and carries up to 50 pounds
  • Exposed to potentially hazardous materials
  • Regularly works on a computer for approximately 4–6 hours a day
  • Ability to work in standard office environment
  • Ability to work in a classified cleanroom lab environment

Application Instructions:

Interested candidates please send your cover letter and resume to careers@gmpcenter.com

 

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