Manufacturing Process Technician

Location: Clayton

Job Title:

Manufacturing Process Technician

Job Description

This role supports critical manufacturing processes in a regulated biotechnology environment, focusing on the production of life-changing therapies. The Manufacturing Process Technician performs hands-on product manufacturing and in-process support, follows strict cGMP and quality guidelines, and contributes to process improvements and cost reduction initiatives. The position requires careful documentation, adherence to established procedures, and collaboration with cross-functional teams to ensure safe, efficient, and compliant operations.

Responsibilities

+ Perform day-to-day product manufacturing activities in accordance with established procedures and cGMP requirements.

+ Provide product manufacturing support activities, including preparation, setup, and shutdown of equipment and processes.

+ Complete routine documentation associated with the manufacture of products, ensuring accuracy, completeness, and compliance with quality and regulatory standards.

+ Support in-process activities and product development tasks as directed by a supervisor, following written instructions and protocols.

+ Incorporate pre-planned process improvements and cost reduction initiatives into manufacturing operations as directed.

+ Perform area equipment and process validations in accordance with approved validation procedures.

+ Conduct in-process product testing following standard procedures to verify product quality and process performance.

+ Support manufacturing activities in other departments when requested by a supervisor, contributing to a collaborative and flexible work environment.

+ Perform all job duties and responsibilities in a compliant and ethical manner in accordance with applicable healthcare laws, regulations, industry codes, and internal standards.

+ Adhere strictly to cGMPs, established manufacturing practices, and quality regulations and guidelines at all times.

+ Follow and execute established written instructions and batch records accurately, escalating issues when necessary.

+ Utilize basic math skills and knowledge of the metric system to perform calculations related to manufacturing processes.

+ Use computer systems, including Microsoft Outlook, PowerPoint, and Word, to complete documentation, communication, and reporting tasks.

+ Work with computerized inventory systems, such as SAP, to support material handling and inventory accuracy when required.

+ Operate stand-up and sit-down forklifts safely, when trained and authorized, to move materials and products within the facility.

+ Apply training and knowledge to understand and mitigate risks associated with processing, handling, and storing hazardous materials.

+ Plan and execute daily work activities according to the production schedule and adapt to changes as needed while maintaining productivity and quality.

+ Communicate clearly in both written and verbal form with team members, supervisors, and other stakeholders to support effective operations.

Essential Skills

+ High school diploma, associate degree, or equivalent with a minimum of five (5) years of experience, preferably in a relevant manufacturing environment, or a bachelor's degree in a science discipline with one to three (1-3) years of experience.

+ Minimum of one (1) year of related experience, preferably in a GMP warehouse or pharmaceutical industry.

+ Knowledge of cGMP operations and regulated manufacturing practices.

+ Ability to understand and execute established written instructions, batch records, and standard operating procedures.

+ Basic math skills, including familiarity with the metric system, to perform calculations related to manufacturing and testing.

+ Basic computer skills with competency in Microsoft Outlook, PowerPoint, and Word.

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Experience with or ability to learn computerized inventory systems; experience with SAP is a plus.

+ Good written and verbal communication skills to document work and interact effectively with colleagues and supervisors.

+ Training or experience demonstrating an understanding of the risks associated with processing, handling, and storage of hazardous materials.

+ Ability to operate stand-up and…