Description 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.
The Manufacturing Associate III position is responsible for executing commissioning and validation activities in addition to other facility start-up support activities. 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 regulation which could apply.
This position is expected to demonstrate skills of the Manufacturing Associate III, which include:
developing a process understanding of primary work areas (Buffer prep, IG Bulk and/or Purification). 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. Ensure execution of processes in production while strictly adhering to all regulations which could apply.
In addition, the Manufacturing Associate is expected to:
- Understand supplier/customer process streams and interdependencies.
- Ensure timely and accurate generation of process documentation, and review documentation
- Train others on complex processes and explain process to others.
- Execute minor document Change Control
- Issue documents.
- Generate work orders.
- Must have customer services and leadership attitude to take ownership of any maintenance problem.
- Sets up, Operates and maintains aseptic filling process equipment for ongoing operations. This may include COP washers, Autoclaves, Tank CIP/SIP stations, Rotary Vial Washers, Depyrogenation Tunnel, Isolater and Vial Filler.
• Participates in the commissioning, start up, evaluation of new equipment.
• Performs preventative maintenance inspections concerning operation of equipment and mechanical condition of equipment.
• Responsible for participating in new equipment installations by interfacing with the maintenance department and process project engineers.
• Demonstrated ability to troubleshoot mechanical and electrical components.
• Perform general troubleshooting and maintenance of equipment while maintaining production schedule.
• Provides training to other Manufacturing Associates.
• Operate various HMI screens (PLC, Delta V) in support of process equipment (i.e. washer, autoclave, filling line, cap machines, etc.).
• Follow instructions for completion of job tasks.
• Complete written documentation of work performed.
• Must possess the ability to work independently and effectively with peers, and display strong interpersonal and organizational skills. Qualifications
• Bachelor's degree in Science/Engineering or
• Associate Degree or equivalent and 4+ years of experience or
• High School diploma with 6+ years of experience
• Atleast 4 years of maintenance experience with a focus on pharmaceutical, food industry, and/or laboratory equipment, troubleshooting & repair within a cGMP environment
• Atleast 3 year's experience in a clean room or GMP/regulated manufacturing environment
• Must be able to read and follow detailed written/electronic instructions and have good verbal/written communication skills.
Equal Employment Opportunity
- 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.
- 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.
Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
EEO is the Law
EEO is the law - Supplement
Pay Transparency Policy Reasonable Accommodations
Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.