Careers

Plant Engineer - Level II


SUMMARY

This position will support the design, planning, construction and maintenance of buildings, utilities, and associated property at all NorthStar campus sites. This position will act as the technical leader for design and maintenance of GMP R&D and production facilities. All projects and duties will be completed in compliance with applicable cGMP, FDA, OSHA and all other regulatory agency standards.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following, other duties may be assigned:

Support the planning, construction, and maintenance of manufacturing system facilities.
Support facilities functions to ensure facilities are prepared at all times for FDA inspections and are in compliance with applicable regulations.
Lead the planning, approval and execution complex or multi-trade projects requiring engineering design or design by outside consultants or contractors.
Provide support for unplanned, unexpected or urgent facilities issues which require immediate action.
Effectively communicate to NorthStar staff to reduce and minimize impacts of facilities projects to business operations.
Maintain current and accurate facilities drawings which accurately show any modifications, alterations or improvements to the facilities or facilities systems.
Support the Environmental, Health and Safety Program to maintain compliance with OSHA and all other applicable regulatory agency standards.
Support facility process performance metrics, including analyzing, tracking, and reporting workload, quality, safety, and cost performance for facilities and utilities.
Analyze, develop and support maintenance of building automation systems for controlling, monitoring, alarming, and reporting building utility systems performance.
Overseeing contractors or vendors performing work within NorthStar facilities to ensure work is performed correctly and meets requirements.
All written documents shall comply with GDP.
Effectively communicate safety and quality issues raised by customers, or staff in a timely manner.
Support NorthStar’s Quality System and Health and Safety Program by following policies and procedures.
Ability and willingness to travel up to 20% of the time.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE

Bachelor’s degree in Engineering. Previous experience/internships in medical devices or pharmaceutical industry preferred.

COMPUTER SKILLS

Proficient knowledge of Microsoft Office software programs, including Outlook, Word, Excel, PowerPoint, Project and SharePoint. Experience working within a Computerized Maintenance Management Software (CMMS) and AutoCAD preferred.

OTHER QUALIFICATIONS

Understanding of federal, state, and local building codes and regulations
Excellent communication skills, both written and verbal presentation
Strong problem-solving skills
Ability to manage multiple projects simultaneously
Ability to interact well at all levels of the organization
Adaptable to change in the work environment

If you are interested in applying for this position, please forward your resume to [email protected] with the position title in the subject line.

 

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