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Manufacturing Tech Specialist

3 months ago

West Torrington, United States Aptyx Full time
Job DescriptionJob Description

Job Summary: We are seeking a highly skilled Manufacturing Technology Specialist with expertise in Good Manufacturing Practices (GMP) and a strong background in medical device or pharmaceutical manufacturing. This role is pivotal in ensuring the efficient operation of manufacturing processes while maintaining the highest standards of quality and regulatory compliance. The ideal candidate will have hands-on experience in both manufacturing technology and medical device/pharmaceutical production environments.

Key Responsibilities:

  1. Manufacturing Process Oversight:

    • Develop, implement, and optimize manufacturing processes and procedures to enhance productivity and product quality.
    • Troubleshoot and resolve issues related to manufacturing equipment, processes, and materials.

  2. GMP Compliance:

    • Ensure all manufacturing processes comply with GMP regulations and guidelines.
    • Conduct regular audits and inspections to verify adherence to GMP standards.
    • Develop and revise SOPs (Standard Operating Procedures) in line with GMP requirements.

  3. Quality Assurance:

    • Collaborate with Quality Assurance teams to ensure that all products meet regulatory and quality standards.
    • Participate in investigations of deviations, non-conformities, and product recalls.

  4. Regulatory Affairs:

    • Stay updated with changes in regulatory requirements and standards relevant to manufacturing and medical devices.
    • Assist in the preparation and submission of regulatory documentation and filings.

  5. Training and Development:

    • Provide training to manufacturing personnel on GMP, quality control, and manufacturing procedures.
    • Develop and deliver training programs to ensure all staff are knowledgeable about GMP and other regulatory requirements.

  6. Continuous Improvement:

    • Implement continuous improvement initiatives to enhance manufacturing efficiency and reduce waste.
    • Utilize Lean Manufacturing and Six Sigma methodologies to optimize processes.

  7. Documentation and Reporting:

    • Maintain accurate and up-to-date manufacturing records, including batch records, equipment logs, and change control documentation.
    • Prepare reports on manufacturing performance, quality metrics, and compliance audits.

Qualifications:

  • Education: Degree in Engineering, Life Sciences, Chemistry, or a related field. Advanced degree preferred.
  • Experience: Minimum of 3 years of experience in manufacturing technology with a focus on GMP compliance in a medical device or pharmaceutical environment.
  • Certifications: Relevant certifications in GMP, Lean Manufacturing, Six Sigma, or other related areas are a plus.
  • Skills:
    • In-depth knowledge of GMP regulations and guidelines.
    • Strong understanding of manufacturing processes, equipment, and technologies.
    • Proven ability to troubleshoot and resolve technical issues.
    • Excellent communication and interpersonal skills.
    • Proficient in using manufacturing and quality management software.

Physical Requirements:

  • Ability to work in a manufacturing environment, which may include standing for long periods, lifting moderate weights, and exposure to various chemicals and machinery.

Work Environment:

  • The position will primarily be based in a manufacturing facility. Some travel to other company locations or supplier sites may be required.