$67000 - $80000 Year
Monday to Friday
Day shift
Dental insurance
Vision insurance
401(k)
Tuition reimbursement
Requires a high school diploma and 0-2 years related industry experience or an Associate's Degree in Life Sciences/Engineering field
Biotech Certificate would be ideal
Can follow written instruction in the form of Batch Records, Form Preps, Technical Protocols and Procedures
Prior troubleshooting skills and full awareness of current Good Manufacturing Practices
Proficient computer skills
May require weekend or holiday off shift support and flexibility to adjust work schedule to meet production demands
Proficient in Aseptic Technique
Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection
Can stand for 6 hours in a production suite
Can climb ladders and work platforms
Stooping or bending to check or trouble-shoot equipment operations
Can lift, pull or push equipment requiring up to 25-50 lbs. of force
As the Manufacturing Associate, you will perform routine and critical manufacturing operations, including work functions in Cell Culture, Purification, Solution & Equipment Prep areas
You will operate production equipment according to standard operating procedures (SOP's) for producing clinical and/or commercial products
You will report to the Supervisor, Manufacturing
Carry out cGMP manufacturing operations using Standard Operating Procedures (SOP), Batch Records and Form Preps
Troubleshoot and resolve basic process related issues including recognizing and escalating deviations
Execution of critical and routine activities to support production
Perform Batch Record, Logbook and Form Prep requests
Enter data in the Laboratory Information Management System (LIMS) , or MODA other business systems
Review GMP documentation
Sample preparation and testing
Identify changes needed to documentation
Participate in tiered visual management system and support CI initiatives
Manage equipment and support facility related projects including initiating work orders, assembly and disassembly of process equipment, perform scheduled cleaning and standardization of equipment
Support change over activities and execution of equipment and process qualifications and validation
May perform as a subject matter expert for equipment or systems
Identify process deviations, troubleshoots issues and identifies process improvements
May require interaction with equipment, technical and supply item vendors
Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet, and body
This may include additional hearing protection for loud areas
To ensure "Essential Personnel" are safe during inclement weather situations Shire may provide lodging, shuttle service, and food (depending on the severity and duration of the inclement weather event)
Communication
Self-management
Computer
No experience needed
Manufacturing
5
General Location, within a limited area