At Shire, we are proud and grateful to employ military veterans and thank them for their contributions to our company and our country. See where your military experience can play a role at Shire by using our military skills translator job search tool below:
Changing lives. Building Careers.
Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.
The Senior Calibration Technician is responsible for calibration and troubleshooting of critical analytical and process instrumentation and control loops used in GMP processes at the Integra Collagen Manufacturing Center (CMC). The Sr. Analytical Calibration Technician ensures that all calibration activities protect the identity, quality, durability, reliability, safety, and effectiveness of medical devices and, thereby, protect patient safety.
ESSENTIAL DUTIES AND RESPONSIBILITIES
To succeed in this role, the Calibration Technician is responsible for:
Safety - Ensures that all team members receive training from Integra LifeSciences' Safety department, and are knowledgeable and compliant regarding safety procedures, policies, permits, practices, and awareness. Initiates accident, near miss reviews and incident notifications. Ensures proper housekeeping procedures are maintained. Reviews MSDS in advance of work, and where required.
Quality - Responsible for the team's compliance and meeting the quality standards as defined by Integra's SOPs, GMPs, Global Quality Standards, local procedures, where applicable. Plays an active role in Root Cause Analyses and in the resolution of Deviation, Non-Conformances, CAPAs, and Change Controls, as applicable and as able.
Manage People Effectively - Interfaces with other Maintenance staff, managers and operators in manufacturing and product development.
Calibration Technician Excellence -
Responsible for ensuring the precision and accuracy of laboratory and process instruments, managing calibration procedures, and overseeing a team of contractors and external service providers.
This role requires technical expertise in analytical instrumentation and a commitment to maintaining compliance with industry standards and regulations.
Perform calibration, maintenance, and troubleshooting of laboratory instruments and analytical equipment (e.g., HPLC, GC, mass spectrometers, spectrophotometers).
Develop and implement calibration procedures to ensure equipment meets performance and regulatory requirements.
Analyze calibration results and provide accurate reports with recommendations for equipment adjustments or repairs.
Perform routine checks and preventive maintenance on analytical instruments to minimize downtime.
Assist in the development and updating of standard operating procedures (SOPs) for equipment calibration and validation.
Ensure proper documentation and traceability of calibration activities, adhering to Good Laboratory Practices (GLP) and regulatory requirements.
Collaborate with laboratory personnel to support technical troubleshooting and resolve equipment performance issues.
Oversee and manage external calibration contractors and service providers, ensuring that they meet performance expectations and adhere to safety, quality, and regulatory standards.
Imparts a culture of 6S and continuous improvement in all calibration activities.
Receives calibration certificates from the Calibration Supervisor.
Ensures that the recipient Quality Control, Microbiology, and the Manufacturing departments are informed of the calibration activities.
Ensures that the Calibration supervisor and the operating area are immediately notified of out of tolerance events.
Gathers necessary tools, standards, and spare parts prior to work. Ensure that calibration standards are within their expiration dates.
Documents work on calibration certificate as it is performed, including any follow up activities required.
Informs the Calibration Supervisor if any follow-up tasks required and any spare parts needed.
Upon completion of a successful calibration, affix a label showing the date performed and calibration due date.
Document calibrations on batch records or room logs to cross reference with calibration certificates, where required.
Serve as a project resource to engineering / validation / Quality Control / Microbiology group to assist in the follow up and timely implementation of projects and validation activities.
Informs management of opportunities for continuous improvement.
Must be available to work during July and December shutdowns.
Actively participates in cross-functional teams addressing Deviations, Non-Conformances, and CAPAs, as required.
QUALIFICATIONS
High School Degree, technical school certificate, or relevant military experience equivalent.
3+ years calibration maintenance experience in FDA-regulated environment is preferable.
Knowledgeable in 6S execution in all aspects of calibration services is preferable.
Must use PPE inclusive of gloves, goggles, face shields, head coverings, full head and body suits, and respirators where appropriate and whenever in the Clean Spaces.
Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:
EEO Is the Law (https://www.eeoc.gov) | EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada_veterans_employers.cfm)
Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com or call us at 855-936-2666.
Integra - Employer Branding from Integra LifeSciences on Vimeo (https://player.vimeo.com/video/265760526)