This position is onsite in Oceanside, CA.

Top 3 Qualities:
Technical Writing Ability
Mechanical Work History Preferred
Industrial Tech Writing Experience if not. This does not have to be direct GMP (although that is
preferred). Can be from a heavily regulated industry like Aerospace.

Summary
Responsible for supporting and providing technical advice related to repair, maintenance activities of cGMP production equipment, clean utilities and systems associated with Manufacturing operations. Provide guidance, training as necessary to ensure a broad base of knowledge within the Maintenance group. Review operating parameters and direct changes and modifications while working with the REs (Responsible Engineers) on systems and equipment as necessary.

Job Responsibilities

Provide technical expertise, troubleshoot and repair equipment failures as necessary.
Perform Vendor Quality Audits of service suppliers and oversee vendor quality issues.
Provide some hands-on technical troubleshooting of electrical and mechanical equipment when required.
Revise existing or establish new procedures for the Preventive Maintenance program to comply with cGMP requirements.
Review purchase orders repair materials and parts and provide oversight for maintenance activities.
As part of a cross functional team member focus on overseeing preventive maintenance and repairs with Engineering, Automation, Project teams, etc...
Review and evaluate contract services to ensure maintenance needs are met and evaluate vendors or service contractor performance and make recommendations for contract renewal/cancellation.
Assist Engineering group in preparation of engineering revisions. Attend required training to support changes. Change Requests, Factory Acceptance Testing, software upgrades, etc.
Troubleshoot, revise, and implement process improvements on equipment and process flows as they need changes. Liaison between Maintenance/ISG and Reliability Engineering.
Responsible for supporting all Maintenance groups and Engineering with data analysis and reports from these databases
Provide assistance with identification of spare parts.
Perform other related duties and responsibilities as assigned by management.
All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA).
Follows established safety and environmental guidelines and procedures for all work performed. Immediately reports safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions.
Fosters a positive safety culture in which no one gets hurt.

Education and Experience
Bachelors degree 2-4 years experience
Masters Degree 1-2 years experience
A/A degree along with a Facilities Management Certificate 5 years experience
7 years experience in the areas of manufacturing, engineering and/or Facilities Maintenance.
3 years working in a cGMP, manufacturing environment.

Knowledge, Skills, and Abilities
Proficiency with computer programs MS Word/Excel/PowerPoint, Visio, Project, Calman and SAP.
Ability to read and interpret engineering drawings.
Thorough knowledge and understanding of the following disciplines: Facilities mechanical, HVAC, Central Plant, Clean Rooms, Building Control Management System (BCMS), Instrument Services and Life Safety Systems.
Ability to lead and communicate and be able to work with other people in the organization to accomplish common departmental and corporate goals.
Ability to work independently with minimal supervision, and be very detail oriented.
Ability to adapt to rapidly changing priorities and provide appropriate feedback and assessment of impacted schedules.
Good customer service skills emphasizing the ability to interact and train people of different backgrounds and skill levels.
Excellent communication skills, both written and verbal.
Must be organized and flexible.
Capable of working on multiple tasks with changing priorities.
Work Environment/Physical Demands/Safety Considerations
Works in standard office environment May be expected to be on feet for up to 2 to 4 hours a day.
May climb upwards of 6 flights of stairs to maneuver within the manufacturing facility.
Lifting up to 50lbs may be required.
Environment requires that gowning in the form of hospital scrubs, bunny suits, gloves and steel toe boots be worn
No make up or jewelry can be worn when working in the clean room environment.
May work with hazardous materials and chemicals.
This position is onsite in Oceanside, CA