Manufacturing Associate ( Purification)
Our client is currently looking for a Manufacturing Associate to join the Purification subdivision of the Manufacturing team. This is an exciting opportunity to work collaboratively in performing production processes for GMP manufacturing operations, implementing new systems, process improvements equipment, and procedures, and when needed, serving as floor leaders responsible for scheduling personnel, material, and equipment flow across multiple shifts. The ideal candidate possesses strong computer and multi-taking skills, strong verbal and written communication skills, and experience working in a fast-paced, dynamic environment with limited supervision.
- Executes bioprocess operations successfully in Purification; strong/proven experience in both manual and automated chromatography operations, UF/DF operations, and bulk filtration.
- Performs CIP/SIP operations: Cleaning, assembly, sterilization, disassembly, and operation of primary process equipment.
- Ensures that standard operating procedures (SOPs) and batch records are accurate, and followed in accordance with cGMP regulatory expectations.
- Recognizes and escalates bioprocess operational risks to team lead or Manager prior to failure, to ensure safety and compliance requirements.
- Recommends and executes projects and changes to bioprocess operations to reduce risk and increase efficiency.
- Trains TECHNICIANS on theories and concepts to support bioprocess operations.
- Performs review of GMP documentation and participates in training and development opportunities to gain understanding of compliance requirements and departmental policies.
- Completes required processing documentation including deviation reports, change control, product change over, etc.
- Reviews and signs executed process and solution MBRs.
- Works with floor supervisor to organize work flow on their shift.
- Ensures acceptable quality and quantity of work executed.
- Ensures compliance with company quality systems, safety procedures, and other company policies.
- Other duties as assigned
- Bachelor’s Degree or equivalent work experience
- Minimum of 5 years of directly relevant industry work experience
- Thorough knowledge of GMP regulations (ICH Q7A) as it applies to job function
- Experience working in purification operations
- Thorough understanding equipment and technology as applies to job function.
- Ability to utilize excellent aseptic technique.
- Possesses relevant knowledge in math, science, and engineering disciplines
- Advanced computer skills including work with spreadsheet programs (Excel) and word processing (Word).
- Organizational and communication skills necessary to plan and execute work flow.
- Detail oriented with the ability to complete written and verbally assigned tasks following specific procedures.
- Judgment required to apply industry practices and company policies and business systems to functional area.
- Ability to manage time effectively.
Our client values its employees, and this is reflected in the compensation and benefits packages we offer.
These packages include:
- Competitive base pay
- An annual bonus program based on company and individual performance
- Comprehensive benefits, including generous paid time off
- A dynamic and challenging work environment
- Opportunities for career development and advancement
Benefit Programs for U.S. Employees
We also offer a wide range of programs to help employees stay healthy, be financially secure, take a break from work, enhance career development, and have fun at work. A comprehensive benefits package is offered to regular full-time and part-time employees (working 24 or more hours per week) and, in some cases, their dependents.