Process Engineer

  • location: Exton, PA
  • type: Permanent
  • salary: $106,000 - $109,000 per year

job description

Process Engineer

Job Title: Sr. Parenteral Process Engineer

Position Description

  • This Sr Engineer will be responsible for supporting the development and customer adoption of container closure system products.
  • The role will incorporate technologies and methodologies from other industries to provide versatile solutions and effect improvements.
  • The individual will bring excellent analytical, engineering, and leadership talent to the Parenteral Processing Group.
  • This Sr Engineer will collaborate with designers, fabricators, SMEs, and technology experts in both related and unrelated fields in support of innovation and implementation of process improvements.
  • Sr Engineer will be accountable to provide designated characterization support in the development of new Parenteral products, develop new capabilities and innovation
Position Responsibilities

  • Lead the evaluation and development of parenteral processes required to support container closure systems.
  • Work collaboratively with other departments to introduce pharmaceutical processing expertise and the user's perspective (voice of customer) globally and cross-functionally into the development cycle from concept to end use.
  • Develop user requirements, functional and design specification for procurement, design, and qualification of new parenteral processing equipment and systems.
  • Provide in-depth knowledge and experience to support deviation investigations and product impact assessments.
  • Delivers acceptance test and qualification protocols.
  • Manage the transfer of knowledge and understanding of critical attributes for container closure systems throughout a pharmaceutical fill-finish process.
  • Build and maintain relationships with strategic vendors to facilitate the identification of new solutions.
  • Lead supplier qualification activities for parenteral processing system suppliers.
  • Manage vendors, consultants and contractors for capital project execution.
  • Apply project management techniques to develop timelines, deliverables, manage resources, and drive strategic projects to completion within budget and on time.
  • 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, or mechanical engineering.
  • Experience: 5-8 years of experience of progressive and relevant work in pharmaceutical manufacturing and parenteral processing.
  • Experience with applying project management, validation and risk management processes to parenteral processing and pharmaceutical manufacturing.
  • 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 excellent written and verbal communication and the ability to build effective internal and external relationships.
  • Experience working with cGMP and Process Qualification
PREFERRED QUALIFICATIONS:

  • Education or Equivalent Experience: Master's in chemical, mechanical, process engineering, or equivalent
  • 5 plus years of experience in parenteral manufacturing.
  • Experience creating technical specifications for automated manufacturing equipment is highly desired
  • Excellent mathematical and/or statistical skills
  • Project Management Professional (PMP) certification
  • Working knowledge of regulations and standards that apply to computerized systems in pharmaceutical manufacturing.
  • Proficiency in Lean Six Sigma
TRAVEL REQUIREMENTS:

  • Travel (25%-40%) to foreign and domestic facilities and suppliers for project management and coordination.

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