Associate Manufacturing I

• Involve in hands-on execution of the plant operations and assist Manufacturing Associates in troubleshooting
• Monitor and analyze processing parameters for atypical trends and improvement opportunities
• Perform solution and equipment preparation
• Perform raw material and singe use parts staging and dispensing with additional logistical support responsibility
• Stage components for autoclaving and washing
• Perform filter integrity testing of sterilizing filters
• Perform environmental monitoring of classified manufacturing cleanroom
• Support in-process testing of production samples, prior experience with analytical instrument will be a plus point
• Actively support continuous improvement initiatives
• Support Safety audits
• Adhere to any applicable EHS requirements
• Ability to adhere to regulatory requirements, written procedures and safety guidelines
• Ability to evaluate documentation/data according to company and regulatory guidelines
• Ability to interact with inspectors (internal and external)
• Ability to interpret and apply Good Manufacturing Practice (GMP) knowledge
• Basic statistical mathematical skills
• Ability to organize work and handle multiple priorities and meet deadlines
• Ability to understand, apply and evaluate basic chemistry, biology and physical principles
• Regulatory knowledge
• Understanding of analytical methods
• Ability to apply ergonomics principles to the work environment and maintain focus during repetitious tasks over the course of a shift
• Some tasks performed consists of occasional strenuous, repetitive movements involving the following bending, hand/wrist twisting and reaching out for height on a daily basis, as well as standing for the long hours on the production floor in accordance to shift duration
• Ability to perform manual lifting, carrying, pushing and/or pulling items with an average weight of <12kg on production floor with or without the assistant of mechanical aid

All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.

We are all different, yet we all use our unique contributions to serve patients.

• Bachelor's Degree and 2 years of directly related experience OR
• Associate's Degree and 4 years of directly related experience OR
• High School Diploma / GED and 6 years of directly related experience
• Possess minimum 0 - 2 years of relevant experience in the biotechnology, pharmaceutical or petrochemical industry. Fresh graduates will be considered
• Knowledge of plant and unit operations (autoclave, parts washers, process equipment), good problem-solving skills
• Demonstrate commitment to cGMP, EHS compliance aspects of clean-room plant operation, prior experience and demonstration of cGMP knowledge is a plus
• Excellent self-motivated team player with hands-on attitude and good communication skills
• Experience with Emerson DeltaV, LIMS, TrackWise
• Ability and willingness to work any shift in support of operations that may include 24/7
• Ability to perform basic computer operations, such as ability to navigate in MS Office, use email, and complete training using LMS.
• Ability to understand, apply and evaluate basic chemistry, biology and physical principles
• Mechanical ability/expertise

Your selection for this role will be subject to fulfilling the medical requirements of this job scope. If so, you will be informed of the medical check(s) that you may need to undergo. All medical related expenses incurred from this medical check shall be borne by the company.