Description:

　　Responsibilities:

　　• Effectively demonstrates understanding of GMPs and how they apply to specific responsibilities.

　　• Practices safe work habits and adhere to safety procedures and guidelines.

　　• Follows verbal and written procedures in operating production equipment and performing processing steps; accurately completes appropriate production documentation.

　　• Maintains cleanliness and orderliness of process area.

　　• Ensures production area is stocked with supplies.

　　• Performs batch record review, procedure revisions, and work order generation.

　　• Utilizes manufacturing knowledge to improve process operations and affect positive change.

　　• Supports in and or leads in Commissioning and Validation activities.

　　• Assists in the creation and revision of manufacturing documentation by providing input to technical composition of document.

　　• Maintain equipment operation through responsive troubleshooting, repairs and following operations guidelines.

　　• Document all production efforts in appropriate logs, forms, reports and databases.

　　• Maintains safe and clean work environment by following current good manufacturing practices (cGMP), and standard operating procedures; complying with legal regulations; monitoring environment.

　　• Enhance organizational reputation by striving to meet and exceed performance expectations.

　　• Identifies and assists in the corrective actions of processing related issues.

　　• Performs other related duties as assigned to meet departmental and Company objectives.

　　• Assists in the identification and implementation of continuous improvement opportunities.

　　• Uses ability to complete tasks in a compliant and safe manner.

　　• Adheres to all cGMPs, compliance/regulatory mandates and quality requirements.

　　Skills:

　　cell therapy, t cell, GMP, batch record, batch record review, biologics, tcr, validation, manufacturing technician, Lab Technician, Laboratory Technician, cell biology, flow cytometry

　　Additional Skills & Qualifications:

　　Requirements:

　　• High School Diploma or GED is required

　　• MINIMUM of 5 years of experience in cleanrooms or manufacturing setting is required.

　　• Must be able to read, write and speak English fluently.

　　• Experience in reviewing and creating controlled documents.

　　• After safety training, must be able to perform required tasks in fully compliant manner.

　　• Must possess strong documentation and communication skills.

　　• Must be able to lift and transport (using carts or wheelies) packages weighing up to 5O pounds.

　　• Extensive walking throughout the facility will be required.

　　• Must be able to use a company-issued computer and have at least intermediate skills in Microsoft Word, Excel, Outlook, and PowerPoint programs needed to perform job.

　　Diversity, Equity & Inclusion

　　At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

　　Hiring diverse talent

　　Maintaining an inclusive environment through persistent self-reflection

　　Building a culture of care, engagement, and recognition with clear outcomes

　　Ensuring growth opportunities for our people

　　Actalent is an equal opportunity employer.

　　About Actalent

　　Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.