Production Tech VMF (No Titer) - I (Assistant)

Spectraforce Technologies, Inc.; North Carolina; In loco; USD 35.000 - 52.000; Tempo pieno

Descrizione del lavoro

Spectraforce Technologies, Inc. in Durham, NC is seeking a Production Technician to support end-to-end processing of drug substances and products in a safety- and quality-focused environment.

You will contribute to continuous improvement and teamwork while operating and troubleshooting manufacturing equipment. You will also participate in Kaizen events, uphold GDP practices, and maintain thorough documentation.

Competenze

• High School Diploma/GED or higher.
• Minimum of one year of experience in a relevant field.
• Demonstrated written and verbal communication skills.
• Ability to pass aseptic gowning qualifications.
• Computer literacy (internet, e-mail, spreadsheets, word processing).
• Willingness and ability to lift 50 lbs, bend, stoop, squat, crawl, twist, climb ladders, and wear a respirator.
• TB titer and Chest X-ray clearance required.

Mansioni

• Author, review, and/or edit operations and technical documentation (Batch Records, SOPs, Job Aides, training, and engineering documents).
• Identify and address compliance, environmental, safety, and process deviations with appropriate personnel.
• Participate in team meetings, HAZOPS, waste walkthroughs, 5S, kaizen events, and other trainings.
• Execute and own production targets for assigned areas, including cleaning, setup, operation, and troubleshooting of equipment.
• Maintain excellent recordkeeping and housekeeping.
• Drive a culture of continuous improvement by implementing and raising ideas to increase group success.
• Participate in Kaizen events and protocol execution to support OPEX functions.
• Maintain detailed knowledge of equipment and processes.

Conoscenze

Communication skills

Aseptic gowning

Computer literacy

Lift 50 lbs

Formazione

High School Diploma/GED

Associate's Degree in science or related field

BioWork Certificate

Strumenti

MES

SAP

DeltaV

Descrizione del lavoro

Role: Production Technician

Location: Durham, NC

Duration: 12 month

Overview:

Join our Manufacturing Operations team dedicated to producing high-quality therapies for patients. This role involves working in a dynamic environment focused on safety and quality, contributing to the end-to-end processing of drug substances and products while fostering a culture of continuous improvement and teamwork.

Key Responsibilities:

• Author, review, and/or edit operations and technical documentation (Batch Records, SOPs, Job Aides, training, and engineering documents) to support project and future operations
• Identify and address compliance, environmental, safety, and process deviations while coordinating with appropriate personnel
• Actively participate in team meetings, HAZOPS, waste walkthroughs, 5S, kaizen events, and other training/initiatives
• Execute and own production targets for assigned areas, including cleaning, setup, operation, and troubleshooting of equipment
• Maintain excellent recordkeeping and housekeeping
• Drive a culture of continuous improvement by implementing and raising ideas to increase group success
• Participate in activities supporting technical and OPEX functions such as Kaizen events and protocol execution
• Maintain detailed knowledge of equipment and processes

Required Qualifications:

• High School Diploma/GED or higher
• Minimum of one (1) year of experience in a relevant field
• Demonstrated written and verbal communication skills
• Ability to successfully pass and maintain aseptic gowning qualifications
• Computer literacy (internet browsers, e-mail, spreadsheets, word processing)
• Willingness and ability to lift 50 lbs, bend, stoop, squat, crawl, twist, climb ladders, and wear a respirator
• Successful completion of TB titer and Chest X-ray are required

Preferred Qualifications:

• Minimum Associate's Degree in science or related field
• BioWork Certificate (working in an FDA or similar regulated industry)
• Applicable mechanical and project management experience
• Experience with automated systems (MES, SAP, DeltaV, or similar)
• Familiarity with regulatory requirements and Good Documentation Practices (GDP)
• Demonstrated ability to work both independently and as part of a team
• Aseptic behaviors and techniques, cRAB/Isolator experience, and environmental monitoring experience are significant advantages