Production Specialist

3 days ago


Portsmouth, New Hampshire, United States Tailored Management Full time
Job Overview

The Production Specialist will play a critical role in supporting the production of therapeutic proteins (Active Pharmaceutical Ingredients - API) in compliance with current Good Manufacturing Practices (cGMP). Working under close supervision, the specialist will learn and perform essential tasks, including operating equipment, monitoring production processes, and performing basic laboratory techniques. The role involves working in a clean room environment and following Standard Operating Procedures (SOPs) to ensure proper documentation, aseptic handling, and facility cleanliness.

Key Responsibilities
  • Process Execution: Execute written procedures and recipes for protein manufacturing, ensuring timely and efficient production.
  • Equipment Management: Set up, operate, and monitor production equipment for Clean-in-Place (CIP) and Steam-in-Place (SIP) processes, maintaining optimal performance and safety standards.
  • Laboratory Support: Conduct pH and conductivity measurements, perform sampling, and assist in routine sanitization tasks, contributing to the maintenance of a clean and organized laboratory environment.
  • Material Handling: Transfer raw materials and chemicals throughout production areas, adhering to safety protocols and quality control measures.
  • Documentation: Complete required documentation in both written and electronic forms in adherence to cGMP and Good Documentation Practices (GDP), ensuring accurate and timely record-keeping.
  • Clean Room Maintenance: Perform routine cleaning, sanitization of facilities, and equipment in support of 6S programs, maintaining a clean and safe working environment.
  • Administrative Support: Participate in shift exchanges, meetings, and projects, handling email communications and other administrative tasks as assigned by management.
  • Additional Tasks: Perform any additional duties as assigned by management, demonstrating flexibility and a commitment to team success.
Requirements
  • Educational Background: A scientific degree or related coursework is preferred, with experience in manufacturing or a strong interest in the sciences being advantageous.
Key Skills
  • Recipe Execution: Ability to follow written procedures and recipes for protein manufacturing, ensuring accuracy and efficiency.
  • Laboratory Techniques: Understanding of basic laboratory techniques, including pH and conductivity measurements and sampling.
  • Problem-Solving: Mechanical aptitude and problem-solving skills, with the ability to adapt to changing situations and troubleshoot equipment issues.
  • Computer Skills: Proficiency in computer skills, especially with automated systems, and the ability to learn new software and technologies.
  • Attention to Detail: Strong attention to detail and ability to work in a regulated environment, ensuring accuracy and compliance with cGMP and GDP.
Estimated Salary

$60,000 - $80,000 per year, depending on experience and qualifications.

The estimated salary range is based on industry standards for this role and location. The actual salary may vary based on individual qualifications and company factors.


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