Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.
The Calibration Supervisor primary responsibility is the day-to-day oversight and supervision of the metrology/calibration program and personnel. This includes ensuring the on-time delivery of all planned and unplanned calibrations in a compliant manner as well as oversight of the program procedures and methodology.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• The individual will perform various duties as required to support 24/7 Plant and Process operations in a cGMP environment. Must be able to respond to emergency on call.
• Responsible for ensuring that all day-to-day calibration activities are completed as scheduled.
• Supervise/Manage the calibration technician’s daily work and tasks.
• Lead calibration recruitment efforts for all open technician positions.
• Perform planned and unplanned Calibration activities.
• Work with and manage vendors.
• Maintain records of calibrations, repairs, parts and equipment.
• Supports and maintains the departmental training program.
• Supports individual developments plans for the department.
• Manages the OE programs for the department, including 6S and 8-waste programs.
• Reviews and interprets analytical and statistical data, calibration issues and performance trends
• Troubleshoot mechanical, equipment, procedural and process problems as appropriate in support of calibration activities.
• Develop and maintain Calibration Maintenance documents, Standard Operating Procedures, schedules and reports.
• Write Deviations, CAPAs, Change Controls and OOT.
• Provide calibration technical support to Production, QA, QC, Facilities and Validation.
• Will assist in failure investigations (root cause) and help provide corrective/preventive actions to Deviations and equipment failures.
• Must comply with all applicable rules and regulations of Emergent and the Pharmaceutical / Biotech industry. This includes FDA regulations such as cGMP, GDP, EH&S regulations and company regulations such as the employee handbook.
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.
MINIMUM EDUCATION, EXPERIENCE, SKILLS
• HS Diploma/GED
• One of the following certifications is required; IAS CST, ASQ CCT or US Military Calibration certification (example; Air Force PMEL).
• 5+ years supervisory experience
• Prior cGMP experience.
• Experience working in a clean room and clean manufacturing environment is required.
• Experience with GMP manufacturing systems and equipment (e.g. critical utility systems, purified water systems, clean steam, pharmaceutical gasses, classified HVAC systems) is required.
• Experience with general utility systems, boilers, electrical, HVAC and refrigeration systems.
• Experience with Rockwell Automation-based control system is preferred.
• Experience with Siemens Building Management Systems is a plus.
• Must have the ability to multi-task and coordinate their workload by priority.
• Must have a customer service focus and be quality driven.
• Prior experience in an environment that implemented and maintained advanced Calibration techniques, such as preventive and predictive maintenance programs, is a plus.
There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.
Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.
Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.