This contract position is with one of our direct clients.Please reach out to Navjot - nsingh(at)divihn(dot)com or Pratichi- pjhala(at)divihn(dot)com or Simoneta - spereira(at)Divihn(dot)com for more details about this position. You can also call Navjot - 630 847 1023 or Pratichi at (630) 847 0267 or Simone at 630 847 0953.
Duration: 1 Year
Location: Marion, NC
The person selected will provide support for the Solution Transmission System (STS) project.
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 the required tasks.
3. Assist with the development and documentation of the filter integrity testing process.
4. Assist with the design and documentation of the new external bag rinsing systems.
5. Coordinate the 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 the 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 of recent and related experience.
MS engineering (Mechanical or Chemical preferred) and 0-2 years of recent and related experience.
Experience in pharmaceutical writing and reviewing validation and change control documentation.
Microsoft software suite; MS Project; AutoCAD; Trackwise8 and Revit (nice to have)
Other Duties as Assigned
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. Overtime is worked as required.
Interview Platform: Phone / Video WebEx / if local or within a couple of hours away from the site the manager would like the final interview to happen in person.
2. Experience in pharmaceutical writing and reviewing validation and change control documentation.
3. Previous experience with Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP)
4. Job longevity and stability
5. Education: BS Engineering (Mechanical or Chemical preferred) / MS Engineering (Mechanical or Chemical preferred)
6. Microsoft software suite; MS Project; AutoCAD; Trackwise8 and Revit (nice to have)
7. Local candidates preferred, open to candidates willing to relocate on their own dime
About us: DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.
DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.