Sr Manager, Facilities Engineering

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Sr. Manager, Facilities Engineering

*YOU ARE more than just a title, YOU ARE... a strong leader with the ability to solve problems and develop good team relationships. You will Provide leadership in Facilities Maintenance & Calibration operations at Bioscience Laboratories Irvine and Lead all Maintenance & Calibration activities as well as support licensure of provision for BOTOX® Bulk Drug Substance materials and support Clinical Bulk Drug Substance supply for other pipeline neurotoxins.

YOU WILL:

Be a Strong Leader who will:

Support Technology Transfer, Engineering and Validation department activities required in the facility.

Support the Technology Transfer/Engineering teams to achieve their goals of a successful technology transfer, equipment and/or facility upgrades from schedule. Work on facility and utilities URS's, Specifications, Documentation review and SOP generation.

Support the validation team strategy and timelines for the BLI facility & strategic projects. Provide support for facility and equipment validation, support external validation specialists as required, ensure proper training is received for the maintenance/calibration aspects of the facility and process equipment.

Facilities/Maintenance/Calibration Management:

Manage the Facilities/Maintenance/Calibration functions, ensuring that the utilities and equipment perform efficiently and that spare parts are available as required.

Respond to breakdowns, emergencies, after hours calls.

Ensure that Maintenance & calibration effectively utilizes the SAP and/or RAM systems. Ensure that the PM requirements accurately reflect the needs of the facility/equipment to maintain them in Operational and cGMP condition.

Ensure that the Facilities/Maintenance team is technically competent in the operation, maintenance and faultfinding of all facilities and production utilities and equipment.

Effectively manage and implement Facility/Maintenance repairs, achieved within budgetary and time constraints. (Including shutdown works)

Collaborate and support EHS & Security policies and procedures to provide a safe working environment and compliance with regulatory authorities.

Set-up and maintain a calibrations system for all facilities and process related equipment. Ensure routine re-calibrations are conducted according to regulatory requirements and meeting required timelines

Regulatory Compliance and Validation:

Adhere to the regulatory requirements as laid down by FDA, JP, EU MoH's, Abbvie etc. All Facilities/Maintenance activities must meet AbbVie Regulatory, Quality Assurance and Validations requirements. Ensure that Regulatory, Corporate or Internal Audits generate no critical citations/observations relating to the Facilities/Maintenance & Calibration function.

Ensure that all maintenance & calibration activities are properly recorded and any equipment repairs and modifications are approved and documented in accordance with QA procedures.

Financial:

Develop annual budgets for the Facilities and Maintenance function under Capital and Expense headings. Executes the budget and provide accurate, timely forecasts as required.

Manage the Spare parts stores for content and value accuracy.

Organizational Effectiveness:

Ensures a competent Facilities/Maintenance work force is selected. Develop and maintain good working relationship with all functional areas in the company and facilitate a team based approach to meeting company objectives.

Manage the Facilities/Maintenance personnel and provide evaluation of their on-going performance and results. Implementation of the Company's and Facilities/Maintenance Department's policies, strategies and goals/objectives

Develop a safety culture within the group:

Ensure that adequate training of maintenance personnel is carried out and correctly documented.

Strategic Planning and Development:

Strategic planning is to be part of the daily activities to develop new and better ways to support the goals of the AbbVie organization. Thinking 'out-of-the-box' is to be support/facilitated.

Regulated Responsibilities (including cGMP and EHS)

AbbVie is a regulated company and the incumbent is expected to be fully compliant with all criteria established by governmental agencies, Ministry of Health, and legislative requirements including, but not limited to: the FDA, EMA, OSHA, Sarbanes-Oxley, EPA, DOT, EEOC, and ADA.

Incumbent will work to ensure that the company is following all environmental, health and safety requirements and assure our business practices enhance the welfare of our customers, employees and the community in which we operate.

Qualifications

Qualifications - External

YOU BRING:

1. Degree or higher level qualification in an Engineering/Facilities/Maintenance discipline.
2. Experience in Facilities/Maintenance management position is a requirement.
3. Minimum of five years of experience/responsibility in pharmaceutical/biotechnology industry; strong technical knowledge (real technical knowledge of Utilities/maintenance/process equipment is required), facility validation, process validation and quality control requirements - each is an advantage.
4. Demonstrated ability to receive successful cGMP inspections, e.g., US (FDA) or foreign regulatory agencies
5. Financial experience and knowledge to balance cost with benefit and previous budgetary experience.
6. Team player with strong customer orientation and ability to work in multinational and multicultural environment.
7. Good understanding of computer systems.
8. The individual is required to be Hand's on and focused on issue resolution. The individual must be willing to put the time and effort into a start-up situation and be willing and able to get involved in the detail of the facility and process operation and be able to this over an extended period. This individual must be energetic and motivated to create a high achieving Facilities/Maintenance function

The individual should be technically competent (understand how the equipment functions, common problems, faultfinding, maintenance) in many (but not all) of the following areas,

• Clean Steam generation and distribution system
• Plant steam distribution systems
• Compressed air distribution systems
• City water pre-treatment.
• WFI generation and distribution systems
• HVAC systems.
• Biosafety level containments.
• Clean room design and construction, FFU's
• Clean room certification requirements.
• Equipment installation - Civil, electrical, mechanical
• Pipe sizing, material selection, passivation, surface finish.
• GMP requirements
• Regulatory audit exposure
• Autoclaves
• Fermenters, bioreactors

Systems:

The individual will be responsible for setting up Facilities, Maintenance and Calibration policies and systems including but not exclusively,

• Strategic Facilities, Maintenance & calibration planning.
• Project management and shutdown management.
• Developing maintenance, Calibration training programs

Personal Skills

1. Person management skills, particularly in the technical environment.
2. Good Communications skills.
3. Technical report writing skills.
4. Ability to take a proactive approach to personnel issues.

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.