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Senior Manufacturing Engineer
hace 1 mes
**About Us**
At Integrated Services For Productivity & Validation, Inc, we are committed to providing exceptional services that meet the highest standards of quality and excellence. Our team is dedicated to delivering innovative solutions that drive business growth and success.
**Job Summary**
We are seeking a highly skilled Senior Manufacturing Engineer - Quality Assurance to join our team. The successful candidate will be responsible for ensuring the quality and safety of our products, while maintaining compliance with regulatory requirements.
**Key Responsibilities**
- Develop and implement quality assurance procedures and processes to ensure compliance with regulatory requirements.
- Conduct regular audits and inspections to ensure adherence to quality standards.
- Investigate and resolve quality-related issues in a timely and efficient manner.
- Collaborate with cross-functional teams to identify and implement process improvements.
- Provide training and support to production staff on quality-related matters.
**Requirements**
To be successful in this role, you will need:
- A Doctorate degree OR Master's degree in Engineering and 3 years of relevant experience; alternatively, a Bachelor's degree in Engineering and 5 years of relevant experience.
- Excellent written and verbal communication skills.
- Technical writing experience.
- Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, facilities, and equipment.
- Experience with change control, nonconformance, corrective and preventative actions, and validation practices.
- Experience with Maximo.
- Capable of working and/or submitting Purchase Orders (PO).
- Experience working and escorting vendors.
- Capable of handling multiple tasks, projects and/or priorities at the same time.
- Independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration.
- Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage.
**Estimated Salary:** $120,000 - $150,000 per year, depending on qualifications and experience.
