Manufacturing Technician-4

Job Description

Title: Technician, Manufacturing 4

Duration: 12 Months

Location: Carlsbad, CA

Work hours: In general, hours are 8:00 am - 5:00 PM, the employee must be able to work off-shifts, weekends, and additional hours as required.

Essential Job Functions

• Troubleshooting equipment and process failures
• Recognize common equipment failures and process anomalies
• Assist in Deviation Investigations, Corrective Action, Preventative Action, and Document Training.
• Author Document Change Requests for Batch Production Records, Standard Operation Procedures, Item Specifications, and Qualifications.
• Leadership
• Reinforce cGMP documentation guidelines
• Emphasize importance of quality cGMP compliant documentation to coworkers
• Provide on-the-job training, emphasizing cGMP compliance
• Provide a positive reinforcing, open learning atmosphere
• Tailor training style to meet individual needs
• Set a good example in observance of cGMP and Quality
• Follow up on instructions/suggestions to ensure compliance
• Demonstrate leadership by example and participation
• Compliance with safety guidelines
• Use safety eyewear while inside a manufacturing area
• Know appropriate emergency response procedures
• Know locations of first aid kits, safety showers, spill kits
• Know evacuation route and assembly area to be used in case of fire or earthquake
• Know the location of MSDS binders and understand how the guidelines pertain to operations
• Follow good chemical safety practices
• Comply with all cGMP Documentation and procedures
• Record information accurately
• Make corrections in a timely manner
• Check all necessary calculations
• Review pre-recorded data for accuracy and completion
• Ensure all entries are neat and legible
• Understand operator and verifier responsibilities
• Review labels and equipment calibrations prior to use
• Perform preliminary review of completed documentation
• Keep logbooks updated and accurate
• Comply with cGMP Practices and Regulations
• Generate clear and concise labels for all in-process equipment and materials
• Understand, observe, and practice proper gowning
• Understand flow of materials and personnel in the manufacturing areas
• Maintain clean and well-stocked labs
• Technology transfer
• Assist in the introduction of manufacturing schemes into the GMP manufacturing facility
• Assist with the purchase of equipment required for new processes
• Lead the startup and validation of new equipment with the assistance of the Validation group
• Author the Standard Operation Procedures required to incorporate new production equipment into the manufacturing facility.
• Provide all the necessary training required to incorporate new production equipment into the manufacturing facility.
• Supervise, and perform as needed, the creation and revision of production documents in order to maintain cGMP compliance and efficiency
• Demonstrate consistent initiative in generating documents and in providing revisions for all documents
• Supervise, and perform as needed, employee training
• Ensure that training records are reviewed and regularly updated
• Reinforce cGMP documentation guidelines
• Provide instruction and guidance to coworkers to prevent errors
• Oversee and maintain the departmental training program
• Implement innovative training programs
• Communicate with members of the manufacturing group, and with other departments, as needed to optimize the production schedule
• Provide frequent detailed operations updates to the appropriate members of the Manufacturing group
• Hold operations meetings regularly to establish flow of information
• Effectively and consistently prioritize and delegate daily assignments and projects to the Biologists and Technicians. Ensure that all staff understand, properly prioritize, and execute their assignments
• Write and distribute concise and effective memos, reports, and communiques as required
• Openly address internal audit items to the shift in an appropriate and timely manner
• Compliance with Policies and Regulations
• Compliance with 21 CFR - Parts 210 and 211
• Compliance with SOPs, batch records, forms, logs of use

Qualifications

Basic Qualifications

• Bachelor of Science degree or equivalent work experience.
• Minimum of 4 years of directly related experience.
• Knowledge of biology and chemistry
• Knowledge of relevant unit operations.
• Sterile cell Culture
• Disposable bioreactors / viral vector manufacturing
• Disposable clarification / filtration (pharmaceutical unit operations)
• Ultrafiltration / Diafiltration
• Skid operation / column chromatography
• Bulk Drug Formulation and dilution
• Sterile Fill / Finish
• Working knowledge of desktop computers and technical equipment

Additional Information

Kind Regards,

Sabanaaz Shaikh

Clinical Recruiter

Integrated Resources, Inc.

IT Life Sciences Allied Healthcare CRO

Gold Seal JCAHO Certified ™ for Health Care Staffing

“INC 5000’s FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)