Job Description

** Ideal candidates have a strong mechanical knowledge of manufacturing equipment, electrical, and new equipment installation**

** Candidates MUST BE US CITIZENS**

**Pay Range, $90k - $110k**

Overview:

The Sr. Engineer is responsible for managing projects related to equipment for new or existing product development and manufacturing processes .This includes designing, creating, modifying, installing, and maintaining the equipment and systems required for the manufacturing of company's products. The individual also provides technical and analytical results that drive product feasibility, product verification, and manufacturing process validations.

Essential Functions:

1. Collaborate with Manufacturing Engineering to improve processes, optimize production methods, and enhance efficiency.
2. Assist in specifying, procuring, qualifying, and validating new or modified equipment.
3. Develop and maintain technical drawings for components, equipment, and infrastructure.
4. Administer the Preventative Maintenance Program in IQMS, including scheduling, issuing, and reviewing work orders.
5. Investigate and resolve equipment failures, leveraging expertise in electrical, mechanical, pneumatic, and PLC systems.
6. Develop and execute qualification documentation (IQ, OQ, PQ) to ensure compliance with cGMP and ISO standards.
7. Maintain compliance with SOPs, cGMPs, and ISO requirements, ensuring proper documentation.
8. Oversee project timelines and budgets for new equipment or process updates.
9. Support manufacturing operations, including startup, operation, and shutdown as needed.
10. Assist in training employees on new equipment operation and maintenance.

Education:

• Bachelor’s Degree in Mechanical Engineering or related discipline required.

Background/Training/Skills/Experience:

• 7-10+ years of related experience in manufacturing field.
• Proficient in electrical design/controls, PLC design, pneumatics, mechanical systems, and metal fabricating.
• Solid working knowledge of basic. Computer Aided Design (CAD) software.
• Strong working knowledge of FDA required Design Control process is required.
• Solid working knowledge of GMP and ISO requirements and the validation process is required.
• Working knowledge of writing and performing Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ) protocols and documents is required.
• Previous involvement with installation qualifications, operation qualifications, and process qualifications is highly desirable.

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