Associate Manager Calibrations

Location
Rensselaer, NY, United States
Posted
Apr 18, 2019
Ref
16095BR
Required Education
Bachelors Degree
Position Type
Full time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary: This position will oversee the daily operations of the Calibration Department at the Rensselaer Manufacturing Facilities, including direct management of the team leaders to ensure that all maintenance activities, calibration work records and documents are reviewed, closed, and maintained in a timely manner.

Essential Duties and Responsibilities include, but are not limited to, the following:

• Involved with scheduling the repair and modifications of process and facilities equipment.

• Oversees and schedules preventive calibration work tasks.

• Reviews completed calibration worksheets in BMRAM.

• Reviews New Asset Requests (NARs) in BMRAM to ensure that their tolerances and associated information is correct for new instrumentation that will be placed on calibration schedules.

• Support internal and external GMP inspections.

• Must be available to assist in the after hour call-ins for utility outages, equipment breakdowns, and emergency events with a customer focus approach.

• Track, analyzes, and improves key maintenance parameters such as asset utilization, maintenance cost, PM and calibration compliance, schedule compliance, etc.

• Coordinates calibration activities with the other Facilities General Operational Departments and with the Manufacturing and Facilities Scheduling Departments.

• Assists with the interviewing and hiring of Calibration Department personnel.

• Assists with planning of equipment and system improvements and plant expansions.

• Review the corrective (on demand) Calibration Department's quarterly reports.

• Review NOEs, CAPAs, NOEs, EOEs, and DNFs and assist with the Change Controls (CCs).

• Support study teams that are focused on improving Regeneron's processes, procedures and training

• Writes new Standard Operating Procedures (SOPs) and reviews, updates, and edits existing SOPs

• Enter purchase requisitions and blanket purchase orders (POs) for vendors to ensure that calibrations are completed in a timely fashion.

• Oversee the pipette calibration program and ensure that pipette calibrations are scheduled, reviewed and completed in a timely manner.

• Oversee the Calibration Coordinators to ensure that instruments are being shipped out and received in a timely manner and review their completed work records in BMRAM.

• Review Continuous Improvement (CIs) that are being submitted by the Calibration Department's Coordinators and Technicians and ensure that everyone is submitting at least one CI each year.

Knowledge, Skills and Abilities:

• Coordinate, organize and assign daily activities of operations

• Ability to motivate employees and build team morale

• Continuously drive to improve processes for improved performance

• Support employees, executing against established guidelines and common procedures and policies

• Ability to provide feedback and career counseling

• Ability to effectively manage high-stress situations

• Strong leader and teacher

• Demonstrated flexibility during ambiguous situations

• Ability to identify problems and escalate accordingly

Education and Experience:

• Requires a BS/BA degree.

• 5+ years of relevant experience in a similar position is preferred, including supervisory experience.

• A Level 1 Certified Control Systems Technician (CCST) with the International Society of Automation (ISA) is preferred.

Will substitute relevant experience in lieu of educational requirements.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.