Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmics.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest. Essential Duties and Responsibilities
The position will support the development of a new, state-of-the-art plasma processing facility that will bring Shire additional cGMP capacity for fractionation, purification, filling, and packaging for its biologic medications.
The SR Manufacturing Technician position is responsible for executing commissioning and validation activities in addition to other facility start-up support activities, as needed, then the role will transition to an operational manufacturing shift lead position where it is expected that the incumbent conducts all manufacturing department processes and assists the supervisor as needed. In addition to making routine revisions to documents, this position may rewrite complex procedures or initiate new procedures as applicable. The incumbent has enough applied technical knowledge to perform moderate trouble shooting tasks and will assist in the execution of technical transfer activities. This position has sufficient technical and administrative competence to organize and lead production activities, including demonstrating leadership in state-of-the-art cGMP compliance, and environmental health and safety skills.
Requirements: Education and/or Experience
- Drive schedule adherence on the Manufacturing floor.
- Coordinate activities across the shift.
- Escalate issues or decision effectively.
- Containment of issues as they arise on shift.
- Involved in hands-on execution of manufacturing operations.
- Assist supervisor as needed on shift.
- Accountability for results.
- Support a perfect equipment culture, by assisting maintenance team during implementation of programs such as Total Preventive Maintenance (TPM), equipment reliability, Preventive Maintenance (PM) and Predictive Maintenance (PdM) programs, etc.
- Contribute toward authoring SOPs and Job aids, associated to manufacturing processes.
- Support process technical transfer activity execution.
- Support the implementation of Kanban and 5S systems to assist from CQV to Full production environment.
- Contribute to a culture of safety first in compliance with Environmental, Health, and Safety (EHS) through all manufacturing associates and production engineers. Understand and follow Job Hazard Analysis (JHA) packets.
- Train and explain process to others and ensure execution of processes in production while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply.
- Stay current with biopharmaceutical industry best practices and technologies
- May perform other duties as assigned.
- Must be able to read and follow detailed written/electronic instructions and have good verbal/written communication skills.
- In depth process understanding of primary work areas and manufacturing techniques (e.g. Buffer preparation, fractionation, purification, fill, finish).
- Troubleshoot and identify atypical processing conditions and how to respond to them.
- Basic Knowledge of Delta V, PLC based process control systems. Human Machine Interface (HMI) configuration.
- Basic Knowledge of instrumentation and mechanical equipment such as controllers, indicators, control valves, PLC, analyzers, sensors, pumps etc.
- Understanding of supplier/customer process streams and interdependencies.
- Must have customer services and leadership attitude to take ownership of any maintenance related problem.
- Must be able to read, write and converse in English.
- Must be able to read and follow detailed written instructions and have good verbal/written communication skills.
- Must be proficient in a variety of mathematical disciplines and be able to work with both the metric and US standards of measurement.
- Must have good interpersonal skills and be able to work effectively and efficiently in a team environment.
- May require immunization before performing work within the manufacturing area.
- Must demonstrate importance of working in a regulated environment.
- Must have the knowledge and ability to use a personal computer, electronic mail systems and navigate and conduct searches on the intranet.
- Must have and display the following personal attributes: Integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.
- Experience in a regulated production
• Bachelor's degree in science /
engineering with 1+ years of or
• AA or equivalent and 6+ years of
• High School diploma with 8+ years of
Must have working knowledge of
scientific principles. Scientific or
technical degree preferred.