Manufacturing Engineer

Katalyst CRO; Reedsville (PA); On-site; USD 67,000 - 108,000; Full time

Job summary

A prominent pharmaceutical company is seeking a Manufacturing Engineer in Reedsville, PA. The ideal candidate will lead process development, manage manufacturing specifications, and ensure compliance with FDA regulations. The role requires a BS/BA degree and expertise in manufacturing environments. Strong problem-solving skills and adaptability to Philips QMS are essential. Competitive salary offered, reflecting experience and expertise.

Qualifications

• Experience in FDA regulated business.
• Understanding of IQ, OQ, PQ validation.
• Ability to work with Philips QMS.

Responsibilities

• Lead manufacturing fixture development and process optimization.
• Conduct structured design reviews.
• Manage document compliance and investigations.

Skills

Expert in manufacturing process flow

FDA regulations knowledge

Technical lead in design transfer

Test method validation

Problem-solving skills

Education

BS/BA in Management, Operations, Engineering or related field

Tools

Manufacturing software validation

Job description

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• Expert on manufacturing process flow and design transfer, Lead manufacturing fixture development, process development and qualifications, lead process development and optimization of critical fabrication.
• maintain manufacturing specifications, requirements, and Failure Modes and Effects Analyses (FEMA) in accordance with protocols and FDA guidance documents.
• expert technical lead on design transfer in partnership with contract manufacturers, conduct and lead failure investigations, ensure document management and manufacturing control compliance.
• conduct and manage structured design reviews. works with hardware, software and firmware engineers, user experience specialists and system engineers.
• guide and participate in test method validation, risk assessment, requirement development, protocol and validation report writing.
  
  

Responsibilities

• Expert on manufacturing process flow and design transfer, Lead manufacturing fixture development, process development and qualifications, lead process development and optimization of critical fabrication.
• maintain manufacturing specifications, requirements, and Failure Modes and Effects Analyses (FEMA) in accordance with protocols and FDA guidance documents.
• expert technical lead on design transfer in partnership with contract manufacturers, conduct and lead failure investigations, ensure document management and manufacturing control compliance.
• conduct and manage structured design reviews. works with hardware, software and firmware engineers, user experience specialists and system engineers.
• guide and participate in test method validation, risk assessment, requirement development, protocol and validation report writing.
  
  

Requirements:

• BS/BA degree in Management, Operations, Engineering or a closely related field.
• Maintain, Validate and Release Test Systems in Production Environment, ideally in FDA regulated business.
• Firm understanding of IQ, OQ, PQ and Software Validation requirements and practices.
• Expertise in PFMEA, Gage R&R, test system and manufacturing software validation for medical devices within the manufacturing environment.
• Ability to learn and adapt to Philips QMS and work closely with the Philips Engineering community on new validation methods and re-validation projects.
• Guide and participate in bug testing, identification, and problem-solving.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Industries

  Pharmaceutical Manufacturing

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