Process Engineer

  • location: Exton, PA
  • type: Permanent
  • salary: $145,000 - $150,000 per year

job description

Process Engineer

Job Title: Director, Parenteral Processing

Position Description

  • The Director of Parenteral Processing will be responsible for introducing parenteral processing expertise in the prefill and fill finish process of container closure system products, including developing capabilities and opportunities to further enhance the services and value products.
  • The individual will bring excellent analytical, engineering, and leadership talent to the group.
Position Responsibilities

  • Build team with skill sets appropriate for technical stewardship of container closure solutions.
  • Develop the new Parenteral Processing Facility, which houses technologies that are key to developing the technical expertise of the department, fully expressing increased new capabilities that could provide opportunities for new product offerings and value added key services.
  • Work collaboratively with other departments to introduce pharmaceutical processing expertise and the user's perspective into the development cycle from concept to end use.
  • Build and maintain relationships with strategic pharmaceutical processing vendors including contract manufacturers, filling equipment vendors, and component manufacturers.
  • Assist in the development of strategic plans and propose budgets for Parenteral Processing Department's activities.
  • Lead, coordinate, and direct projects, teams, and studies concerning pharmaceutical fill-finish process development.
  • Provide technical oversight of the development and execution of protocols, documentation and transfer of knowledge, and understanding of critical attributes for container closure systems throughout a pharmaceutical fill-finish process.
  • Assist in the evaluation of new container closure systems to assure they meet customer/vendor/ market requirements prior to release. Generate technical data to communicate the results of such evaluations.
  • Prioritize and direct various programs in order to effectively support design and development of new and innovative container closure systems and implement improvements to existing container closure systems with emphasis on innovation, customer engagement, quality standards, cost effectiveness, and compliance.
  • Mentor and develop Parenteral Processing engineers/chemists/sterility assurance and staff regarding pharmaceutical process technology.
  • Apply project management techniques to develop timelines, deliverables, manage resources, and drive strategic projects to completion within budget and on time.
  • Prepare detailed business plans and personnel development plans.
  • Performs other duties as assigned based on business needs.
  • Conform with and abide by all regulations, policies, work procedures, instruction, and all safety rules.
REQUIRED QUALIFICATIONS:

  • Education or Equivalent Experience: Bachelor's in process, chemical, mechanical engineering.
  • Experience: 15+ years of experience in parenteral process manufacturing and technical support, design for excellence, transfer to manufacturing and/or high value manufacturing.
  • Must have previous regulatory agency interaction specific to audits and filings
  • A minimum of 7 years of management experience in the field of engineering.
  • Strong analytical skills with fundamental understanding of the first principles of engineering.
  • Must be self-motivated, have strong attention to detail, ability to work independently and in team settings.
  • Must have strong leadership, planning, and technical skills needed to successfully execute a complex product and/or process development project. (Will manage a group of 4 to 10 direct/indirect reports)
  • Must have excellent written and verbal communication and the ability to build effective internal and external relationships.
  • Track record of execution, accountability, and strong analytical skills.
PREFERRED QUALIFICATIONS:

  • Education or Equivalent Experience: Master's in chemical, mechanical, process engineering, or equivalent with 10 plus years of experience in parenteral manufacturing.
  • Able to communicate effectively in German strongly desired
  • Other language skills in French and/or Japanese a definite plus
TRAVEL REQUIREMENTS:

  • Travel (25%-40%) to foreign and domestic facilities and suppliers for project management and coordination.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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