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 Ophthalmic. 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.
The Manufacturing Associate II position is responsible for executing commissioning and validation activities in addition to other facility start-up support activities. We are looking for detail oriented people used to working in regulated environments and who want to continue to develop professionally. After validation, the role will then transition to an operational manufacturing shift associate position where it is expected that the incumbent executes all manufacturing department processes in production while strictly adhering to cGMP, environmental health and safety guidelines, and any other related regulations which could apply.
This position is expected to:clean, set up, operate, and teardown equipment such as tanks, filtration systems, chromatography columns/skids, and production lines. In addition, the associate will operate general production equipment such as pH, UV, and conductivity meters, washers, and additional equipment associated with the production process. Monitoring and recording of critical process parameters is required. Perform basic preventive maintenance related to manufacturing equipment. Support the implementation of Kanban and 5S systems to assist from CQV to Full production environment. Must be able to read and follow detailed written/electronic instructions, be comfortable with electronic documentation, and have good verbal/written communication skills.
In addition, the Manufacturing Associate II is expected to:
Requirements: Education and/or Experience
- Develop a process understanding of primary work areas
- Execute activities on manufacturing floor in accordance with schedule; involves effective communication and working with other departments.
- Troubleshoot and identify atypical processing conditions and how to respond to them.
- Provide a moderate level of troubleshooting and diagnosis and assist with repair of equipment such as columns, vessels, skids, and CIP/COP systems; may include executing simple preventive maintenance tasks.
- Basic knowledge of Delta V, PLC-based process control systems, Human-Machine Interface (HMI) configuration.
- Basic knowledge of instrumentation and mechanical systems such as controllers, indicators, analyzers, control valves, sensors, pumps, etc.
- 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
- Must be able to read and follow detailed written/electronic instructions and have good verbal/written communication skills.
- Ability to gain in depth process understanding of primary work areas and manufacturing techniques (e.g. Buffer preparation, fractionation, purification, fill, finish).
- Must have customer services attitude and willingness to assist with any maintenance related problem.
- Must be able to read, write and converse in English.
- 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.
- Experience in a regulated production environment desirable:
- Bachelor's degree or
- AA or equivalent plus at least 1 year of experience or
- High School diploma with at least 3 years of experience.
- Must have working knowledge of scientific principles
- Scientific or technical degree preferred.
Physical Demands/ Work Conditions:
- Must be able to lift, push, pull and carry up to 50 lbs.
- In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.
- Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
- No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the work environment.
- May be working in a loud area that requires hearing protection and other protective equipment to be worn.
- Will work around chemicals such as alcohol that may require respiratory protection.
- May be required to work or be assigned to a different shift as needed.
- Must be able to work weekends or overtime as required.
- Inside working conditions.
- Some clean room and cool/hot storage conditions.