Responsible for the governance of calibration maintenance system that includes the coordination, execution, and compliance with all related programs/system that support and assure reliable Utilities, Environmental and Manufacturing Operations for the site through the Supervision of the Calibration Resources and with cross-collaboration of other business units such as PET, FUME, Laboratory providing operations technical support.
Provides proactive and focused technical expertise and support in Instrument Calibration and Systems Maintenance area. Ensures conformance with company goals, regulatory agencies such GMPs, and SHE requirements in the area of responsibility.
Carries out supervisory responsibilities following the organization's policies and applicable labor laws. Ensures and monitors the proper development of area personnel.
Typical Accountabilities
- Accountable for controlling and administering all phases of the team (including performance appraisals, task coordination, training, development plans, coaching, and career paths).
- Responsible for the governance of the Calibration and Maintenance system, including the strategy and tactical execution such as implementing new systems, maintaining and improving the calibration/ maintenance programs (e.g. record keeping and data trend analysis to find opportunities for improvement)
- Serve as a SME during regulatory inspections (int/ext)
- Provide technical expertise for leading or supporting investigations.
- Responsible for the evaluation of calibration/maintenance program and contracted services for process optimization and cost reduction opportunities while maintaining the operating cost of the area within the approved budget.
- Ensure that the area under his/her responsibility has the necessary procedures according to the manufacturer's operation manual and recommendations and in compliance with the company and regulations.
- Always ensure compliance requirements as per our quality systems for all direct reporters in an area under his/her responsibility.
- Responsible for maintaining a safe operation in the area. A high degree of safe awareness should be promoted to all personnel in the area.
- Ensures that resources have the necessary training and are properly trained to perform the required duties.
- Responsible to perform regular coaching and the performance appraisal process for the employee reported to him/her.
- Undertakes training activities for self-development and professional growth.
- Coordinate the required area activities with the IPR planning group and PETs.
- Lead and deliver continuous improvement within the unit resources and Process Engineering Support Professionals.
- Responsible for having the unit comply with all cGMPs, and SHE regulatory requirements.
- Perform any troubleshooting to the systems/equipment as required by the operations.
- Establish an effective relationship and communication with all areas to have healthy interpersonal relations.
- Support Engineering and Process Engineering Support in the development/implementation of project activities.
- Understand that a culture of continuous improvement relies on a good team dynamic and knows how to assess and resolve serious team conflicts that damage the energy of a team. Promote Cross-collaboration at all times (One team mindset)
- Maintenance and enhancement of own and team technical competence aligned with site strategy.
- Maintain area of responsibility compliance to assure no major or critical observations during regulatory inspections.
- Develops and manages technical resources to ensure programs are conducted in such a manner as to support future business needs and strategies while ensuring robust compliance.
Education, Qualifications, Skills and Experience
Essential
Education / Experience:
- BS in Chemical, Mechanical, Electrical Engineering or equivalent with at least three (5) years’ experience or related technical science, with (3) years of experience in calibration, maintenance and supervisory experience.
- Safety and GMP awareness
Language:
- Fully bilingual (English and Spanish). Must be highly proficient in English, both written and spoken. Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the public.
Computer skills:
- To perform this job successfully, and individual should have knowledge of Database software; Internet software; Inventory software; Project Management software; Spreadsheet software and Word Processing software.
Licenses and registrations:
Date Posted
18-Jul-2024
Closing Date
28-Jul-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.