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Sterilization Engineer - RT

Company:
Absolute Opportunities
Location:
Columbus, Nebraska, United States
Posted:
November 14, 2018

Description:

Sterilization Engineer - RT

Columbus, Nebraska

Essential Functions: Position requires ongoing support of terminal sterilization equipment and processes, along with responsibilities for future sterilization projects. Assist in process system design, capital equipment acquisition, installation and testing of equipment, commissioning of building systems, and validation of facility/process equipment. Assists with continuous improvement of facility systems and projects. This includes facility design, documentation, validation, and maintenance. Regular, punctual attendance is an essential job function. Ability to speak, read and write English. Ensures compliance with our quality systems, policies, procedures and practices and all local, state, federal and our safety regulations, policies and procedures.

Responsibilities:

1. Provides technical guidance as needed. Acts as a mentor and provides leadership for the technical sterilization team. Develops training programs for engineering related to sterilization processes and works directly with sterilization group to certify sterilizer operators.

2. Provide leadership and support for sterilization related projects designed to support the overall strategies of the plant. Lead the installation of new sterilization equipment including optimization of processes and compliance with all applicable regulatory standards

3. Maintains knowledge of developments in state-of-the-art sterilization processing technology.

4. Develop, write, and update process specifications and documentation for sterile pharmaceutical processing equipment including contracts, schedules and purchasing documents.

5. Works with sterilization group to develop protocols for qualification and validation of terminal sterilizing equipment, and routine re-certification of processes in place.

6. Interprets industry standards and regulations to ensure sterilization equipment performances within compliance. Ensures corporate sterilization policies and standards are applied and maintained.

7. Assist with facility process improvements, cost reductions, and manage projects while maintaining project budgets.

8. Coordinates plant shutdown activities for Sterilization operations.

9. Develop and maintain preventive maintenance schedules and spare parts inventories.

10. Ensures calibration of equipment.

11. Provide support to ongoing terminal sterilization operation as needed.

12. Other duties as assigned.

REQUIREMENTS-

Annual respiratory fit test required.

Minimum Knowledge, Skills, or Abilities (KSA’s):

Proficient / Working KSA

Computer skills (Microsoft Office suite, Microsoft Project, Internet, and PLC programming)

Trouble shooting skills

Mechanical and electrical systems knowledge

Project management skills

Medical device manufacturing standard knowledge

Regulatory knowledge (FDA, OSHA, EPA, DOT)

Air pollution control system

Managing change skills

Communication skills

Technical writing skills

Ability to work with highly regulated and complex processes

Ability to work with limited supervision

Ability to read and understand electrical and mechanical schematics and P&ID drawings.

Six Sigma

Relocation Assistance Available - Possible for ideal candidate

Required Knowledge, Skills, and Abilities: (Submission Summary)

1. Bachelor’s Degree : Field of Study, Engineering or technical degree with emphasis in mechanical and

Mechanical and electrical systems knowledge

2. Six Sigma

3. Medical device manufacturing standard knowledge

4. Validation Experience Highly Preferred

5. Air pollution control systems installation/operation / validation experience preferred.

6. Ethylene Oxide sterilization installation / operation / validation experience preferred.

7. Do you have previous Validation Experience.

8. Do you have at least 2 or more years of Technical writing experience?

9. Do you have Medical device or pharmaceutical industry experience?

10. Salary Expectation?

11. Must be a US Citizen or Green Card holder?

12. Complete Current Address