Senior Calibration Technician at United Therapeutics Corporation

Silver Spring, Maryland, United States -

Full Time

Start Date

Immediate

Expiry Date

06 Feb, 26

Salary

110000.0

Posted On

08 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Calibration, cGMP Regulations, Instrumentation Troubleshooting, Technical Oversight, Vendor Management, Documentation, SOP Development, Training, Equipment Maintenance, Process Verification, Corrective Actions, Cross-Functional Collaboration, Lifecycle Documentation, Data Review, Audit Support, Technical Guidance

Industry

Pharmaceutical Manufacturing

Description

California, US residents click here. The job details are as follows: Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs. United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter’s pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option. Who You Are You're mechanically inclined and enjoy being hands on with a variety of different equipment and instrumentation. The Senior Calibration Technician serves as a subject matter expert responsible for performing, coordinating, and documenting calibration activities across manufacturing, laboratory, utility, and warehouse areas. This role ensures all instruments within scope remain calibrated and compliant with internal procedures and regulatory requirements in a cGMP-regulated setting. The Senior Technician provides technical oversight of vendors, contributes to investigations and SOP development, and supports onboarding and training of junior personnel. The position operates with a high degree of independence and collaborates cross-functionally to uphold calibration standards and system reliability. Schedule, coordinate, and perform equipment, system, and instrument calibrations, or oversee vendor-performed calibrations as applicable. Reconcile calibration documentation in accordance with internal procedures and FDA guidelines. Support investigation and closure of calibration-related deviations and assist with development or implementation of corrective and preventive actions as required. Provide advanced support for scheduled and unscheduled calibration and verification work on process-related, GMP-classified, or validated equipment within manufacturing and facilities. Collaborate with other teams as needed, with strict adherence to company SOPs and cGMP requirements. Maintain, test, and troubleshoot calibrated instrumentation such as pressure, temperature, flow, and measurement devices. Determine and implement corrective actions as necessary within scope and capability, initiate escalation when needed, and coordinate resolution efforts with vendors or other support teams. Collaborate with cross-functional teams to assess equipment and instrumentation needs, define specifications, and manage vendor relationships across calibration service providers, OEMs, and suppliers. Engage with vendors to obtain quotes, proposals, and documentation in support of procurement activities. Review work performed by vendors and temporary calibration personnel for technical accuracy, documentation completeness, and proper system entry. Ensure adherence to company procedures and calibration requirements within the calibration function. Complete accurate and compliant documentation for all scheduled and unscheduled calibration events, covering all instruments within the calibration scope. Ensure records are maintained in accordance with GxP expectations using BM-RAM, and support QA requests related to data review or calibration record inquiries. Coordinate and support contract service providers performing calibration activities, including scheduling, access, and documentation. Provide oversight to ensure vendor work complies with site procedures, calibration standards, and GxP requirements. Maintain accurate lifecycle documentation for calibrated instruments in alignment with regulatory and GxP requirements, including installation records, calibration history, and retirement status. Manage internal inventories of standards, consumables, and spare parts, including reordering and documentation. Serve as the site-level Subject Matter Expert (SME) for calibration activities, supporting audits, investigations, and SOP development. Provide technical guidance across multiple buildings and departments, and oversee vendor performance to ensure compliance with calibration procedures and technical standards. Support the drafting and revision of SOPs by providing technical input and review. Contribute to deviation and failure investigations as a subject matter expert. Assist with the creation of calibration-related reports, audit responses, and trend summaries as needed. Support onboarding and on-the-job training of junior or temporary technicians by providing guidance on general and site-specific calibration procedures. Assist in developing familiarity with tools, systems, and practices to minimize downtime and ensure consistent calibration execution. Maintain compliance with training requirements by completing all assigned training within designated due dates For this role you will need Minimum Requirements H.S. Diploma or General Education Degree (GED) 6+ years of experience in a pharmaceutical, food, or chemical manufacturing environment as a calibration technician or equivalent role Extensive experience in instrumentation troubleshooting and repair of pneumatic, electronic and hydraulic control systems Ability to perform electrical repairs in accordance with NEC Strong working knowledge of cGMP regulations Experience with building management system Ability to handle confidential company data, projects, information, etc. Intermediate PC skills and experience with software for tracking and scheduling calibration and preventive maintenance events such as Blue Mountain RAM Preferred Qualifications Associate Degree in engineering, life sciences, or other related technical field or equivalent military training and six years of instrumentation experience or the equivalent combination of education and experience Working knowledge of Adept, CAD, Master Control and Trackwise Job Location United Therapeutics requires this candidate to be 100% on-site at our Silver Spring, Maryland location. The salary for this position ranges from $80,000 to $110,000 per year. In addition, this role is eligible for the Company's short-term and long-term incentive programs. At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good. Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities. We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success. We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work.

Responsibilities

The Senior Calibration Technician is responsible for performing, coordinating, and documenting calibration activities across various areas to ensure compliance with internal procedures and regulatory requirements. This role also involves providing technical oversight of vendors and supporting the onboarding and training of junior personnel.