Senior Process Engineer III

cGxPServe Inc.; Dublin (CA); On-site; USD 107,000 - 134,000; Full time

Job summary

A leading company in the medical device sector is seeking a Senior Process Engineer to oversee the transfer of manufacturing processes between facilities. This role requires strong project management skills, experience in regulatory compliance, and collaboration with diverse teams. The successful candidate will ensure seamless transitions while optimizing processes and maintaining documentation and reporting standards.

Qualifications

• 8+ years of experience in process engineering, preferably in medical devices.
• Proven experience in transferring manufacturing processes.
• Strong knowledge of regulatory requirements and quality standards.

Responsibilities

• Ensure the transferred process adheres to the Device Master Record.
• Develop a comprehensive transfer plan with timelines and resources.
• Collaborate with cross-functional teams to address challenges during transfers.

Skills

Project Management

Analytical Skills

Problem Solving

Communication

Interpersonal Skills

Education

Bachelor's degree in Electrical or Mechanical Engineering

Job description

1 week ago Be among the first 25 applicants

• Design History File: Ensure that the transferred process is adhering to the Device Master Record.
• Process Analysis and Documentation: Analyse current manufacturing processes and create detailed documentation to facilitate the transfer of medical devices to new facilities.
• Transfer Planning: Develop and implement a comprehensive transfer plan, including timelines, resources, and risk assessments, to ensure smooth transition between facilities.
• Cross-functional Collaboration: Work closely with cross-functional teams, including R&D, Quality Assurance, Regulatory Affairs, and Supply Chain, to align objectives and address any challenges during the transfer process.
• Regulatory Compliance: Ensure all transferred processes comply with relevant industry standards, regulatory requirements, and quality assurance protocols.
• Equipment and Technology Alignment: Evaluate existing equipment and technologies to determine compatibility at the receiving facility; recommend upgrades or changes if necessary.
• Process Validation: Ensure that equipment qualification follows the product requirements.
• Training and Support: Provide training and support to facility teams to ensure they are equipped to manage new processes effectively.
• Continuous Improvement: Identify opportunities for process optimization and efficiency improvements before and after the transfer.
• Reporting and Documentation: Maintain detailed records of transfer activities and provide regular reports to management on progress, risks, and outcomes.
  
  

Responsibilities

• Design History File: Ensure that the transferred process is adhering to the Device Master Record.
• Process Analysis and Documentation: Analyse current manufacturing processes and create detailed documentation to facilitate the transfer of medical devices to new facilities.
• Transfer Planning: Develop and implement a comprehensive transfer plan, including timelines, resources, and risk assessments, to ensure smooth transition between facilities.
• Cross-functional Collaboration: Work closely with cross-functional teams, including R&D, Quality Assurance, Regulatory Affairs, and Supply Chain, to align objectives and address any challenges during the transfer process.
• Regulatory Compliance: Ensure all transferred processes comply with relevant industry standards, regulatory requirements, and quality assurance protocols.
• Equipment and Technology Alignment: Evaluate existing equipment and technologies to determine compatibility at the receiving facility; recommend upgrades or changes if necessary.
• Process Validation: Ensure that equipment qualification follows the product requirements.
• Training and Support: Provide training and support to facility teams to ensure they are equipped to manage new processes effectively.
• Continuous Improvement: Identify opportunities for process optimization and efficiency improvements before and after the transfer.
• Reporting and Documentation: Maintain detailed records of transfer activities and provide regular reports to management on progress, risks, and outcomes.
  
  

Requirements:

• A bachelor's degree in electrical engineering, mechanical engineering, or a related field.
• Minimum of 8 years of experience in process engineering, preferably within the medical device industry.
• The successful candidate will be responsible for overseeing the transfer of medical device manufacturing processes from one facility to another, ensuring seamless operation, compliance with regulatory standards, and minimal disruption to production schedules.
• Proven experience in transferring manufacturing processes between facilities.
• Strong knowledge of regulatory requirements and quality standards for medical device manufacturing.
• Excellent project management and organizational skills.
• Ability to work independently and collaboratively in a fast-paced environment.
• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Management and Manufacturing

• Industries

  Research Services

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