Calibration Technician

Sebela Pharmaceuticals is a U.S. pharmaceutical company with a market-leading position in Gastroenterology and a focus on innovation in Women’s Health. Our Vision is to build the leading Gastroenterology company in the U.S., with a complementary focus on innovation in Women’s Health, premised on our expertise in pharmaceutical development and commercialization. Braintree Laboratories, Inc., a part of Sebela Pharmaceuticals, has its contract development and manufacturing organization (CDMO) in Holbrook, MA, offering pharmaceutical-development and in-house manufacturing services for specialty gastroenterology products.

We value dedication, energy, and enthusiasm, and we focus on innovation and results while striving to achieve our corporate mission and vision. Sebela Pharmaceuticals is committed to cultivating an inclusive environment where all employees are treated with respect. We accomplish this by fostering a culture of diversity, equity and inclusion, which is essential to innovation and continuous improvement. Sebela operates from three locations in Roswell, Georgia, Braintree and Holbrook, MA and headquarters in Dublin, Ireland.

In conjunction with the Validation and QC groups, the Calibration Technician is responsible for overseeing the calibration program at the Holbrook Site and ensuring that it is in compliance with current industry and regulatory expectations. This includes calibration, maintenance, troubleshooting, and documentation of manufacturing, laboratory and facility instrumentation.

PRINCIPAL DUTIES AND RESPONSIBILITIES

• Perform calibration, verification, adjustment, and preventative maintenance of manufacturing and laboratory instrumentation not performed by external contractor.
• Responsible for administering the site’s calibration program and ensure adherence to the site’s calibration schedule.
• Provide expert knowledge in establishing instrument tolerances.
• Continuously evaluate the frequency of calibrations based on as found calibration results and out of tolerance events.
• Maintain accurate calibration records, creating calibration reports for all instruments including out-of-tolerance instruments.
• Periodically review the calibration program to ensure that it is maintained in a state of cGMP Compliance and within industry expectations.
• Ensure that all instruments are within the calibration program.
• Maintain a calibration schedule and ensure that calibrations are performed prior to the due date.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential function satisfactorily, be flexible in terms of work hours, and have strong knowledge and experience in managing a calibration program and performing instrument calibrations. The requirements listed below are representative of the knowledge, skills and/or abilities required.

• 3 years of calibration or instrumentation experience in a pharmaceutical, medical device or other regulated manufacturing environment.
• Bachelor’s degree in Life Sciences or Engineering preferred.
• Experience working within cGMP, FDA, and regulatory compliance requirements.
• Familiarity with computerized maintenance management systems and calibration management software.
• Strong troubleshooting and problem-solving skills.
• Exceptional verbal and written communication skills.
• Strong organizational and documentation skills.

Pay Range: $30.00-$47.00 per hour based on experience (this reflects our reasonable and good faith estimate of what will be paid at the time of posting). Competitive benefits package included.