Engineer III (Marion, NC)

Engineer III (Marion, NC)

19 Jul 2024
North Carolina, Asheville 00000 Asheville USA

Engineer III (Marion, NC)

Vacancy expired!

Position: Engineer

Location: Marion, NC – 28752

Duration: 12 Months

Summary:

The person selected will provide support for the Solution Transmission System (STS) project.

Job Responsibilities:

1. Assist Project Manager (PM) in completing all required change control documentation for the project including TrackWise8 activities.

2. Provide guidance to subcontractors and other personnel as needed to successfully accomplish required tasks.

3. Assist with development and documentation of the filter integrity testing process.

4. Assist with design and documentation of the new external bag rinsing systems.

5. Coordinate addition of preventative maintenance tasks and spare parts into the computerized maintenance management system (CMMS).

6. Complete documentation for issuance of asset numbers for the new equipment.

7. Assist with tracking schedule and installation of equipment to ensure work is completed per the design.

8. Tracking and organization of all contractor documentation related to welding, passivation, and equipment/system drawings.

9. Generate required forms to implement design documentation in various document repositories (Drafting, Document Center, etc.)

10. Coordinate requalification of the current filling equipment after connected to the new system.

11. Generate User Requirement Specifications for new equipment and processes.

12. Support efforts to bring the new North Mixing complex into a production state.

Knowledge, Skill and Abilities:

Prefer experience with TQM methods (e.g. six sigma)

Display a solid technical understanding of engineering principles and procedures (e.g. CAD and its application or scheduling a series of technical tasks utilizing software-based tools.

Understand and articulate how own role ties within function or discipline

Demonstration application of engineering principles on individual/small projects.

Learn, understand and apply rigorous quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP)

Required Education and Experience:

BS engineering (Mechanical or Chemical preferred) and 3-5 years recent and related experience.

MS engineering (Mechanical or Chemical preferred) and 0-2 years recent and related experience.

Experience in a pharmaceutical writing and reviewing validation and change control documentation.

Microsoft software suite; MS Project; AutoCAD; Trackwise8 & Revit (nice to have)

Job Details

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