Mgr Maintenance Engineering ServicesSUMMARY
With general guidance, provides maintenance leadership, staff supervision, and technical expertise in support of
facility equipment/systems, utility systems, and/or production suites, ensures systems operate within designed
parameters. Area of responsibility may consist of multiple facilities, disciplines or clients. All work to be completed to
assure minimal impact to production while complying with all cGMP guidelines and Amgen procedures.
FUNCTIONS
1. Support the development of a Maintenance Vision, Mission, Strategies, and Goals that provides a guide to
becoming the best maintenance organization.
2. Develop maintenance metrics to support the benchmarking of site, global, and industry. Develop improvement
strategies based off the benchmarking data.
3. Manage the maintenance department that provides technical, project, emergency response, trouble shooting
and preventative maintenance support for facilities and related equipment.
4. Support consistent global maintenance and operational practices throughout sites.
5. Function as a technical expert to equipment or systems regarding troubleshooting operational issues and point
of contact during compliance inspections. Provides solutions to a variety of technical problems.
6. Develop, maintain, and justify the department budgets.
7. Assure the appropriate level of cGMP and Amgen Values Training for all levels of the maintenance
organization and maintain records for staff.
8. Oversee the development, revision, review, and approval of Standard Operating Procedures/Job Plans that
are owned by the maintenance department.
9. Support project engineering in the justification, prioritization, and coordination of manufacturing projects.
Provide design assistance, as required, using knowledge of both the operations and facilities capabilities and
the knowledge of production requirements.
10. Partner with Compliance and Quality Assurance Departments to ensure maintenance operational strategies
are in alliance with our compliance commitments.
11. Maintain an environment that promotes maintenance flexibility, consistent maintenance practices, and efficient
operations, which prepare us for current and future production demands.
12. Other functions may be assigned.
Basic Qualifications
EDUCATION/LICENSES
Doctorate degree
or
Master's degree and 3 years of directly related experience
or
Bachelor's degree and 5 years of directly related experience
COMPETENCIES/SKILLS
ï‚· Complete knowledge of pharmaceutical/biotech building requirements.
ï‚· Familiarity with validation process and cGMP documentation.
ï‚· Ability to operate specialized laboratory equipment and computers as appropriate.
ï‚· Leadership and team building skills.
ï‚· Excellent verbal and oral communication.
ï‚· Ability to resolve conflicts.
ï‚· Ability to make disciplined decisions.
ï‚· Knowledge of staff relations with the ability to coach mentors and counsels staff when needed.
ï‚· Good organizational skills.
ï‚· Ability to deal with and manage change.
ï‚· Knowledge of basic compensation system practices and methodologies.
ï‚· Strong computer knowledge.
Preferred Qualifications
•Bachelor degree in Mechanical, Electrical or Chemical Engineering
•Experience in Solid Dosage Pharmaceutical Operations
•Experience in operation and maintenance of the following system/equipment:
oPurified Water System
oReverse Osmosis
oContinuous Deionization Unit
oWater for Injection/ Distiller
oSanitary Steam Generator
oAutoclaves
oPlant Steam Boiler
oCompressed Air Systems
oBMS/UMS System
•Maximo CMMS Experience
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