Aseptic Manufacturing Technician

Job Overview:

The Manufacturing Technician is responsible for supporting the overall GMP Fill Finish manufacturing processes, through the application of broad knowledge of theories, techniques, and principles utilized to solve operational and routine tasks in the aseptic production of finished drug product biologics for commercial GMP manufacturing. The Manufacturing Technician will be responsible for the filtration and filling of a range of pharmaceutical products for clinical and commercial use.

Responsibilities:

• Complete and maintain aseptic qualification training.
• Obtain basic understanding of a task, unit operation and/or document (forms and/or SOPs) while aiding with oversight from Manufacturing Technician III and above.
• Attain and maintain gowning qualification per appropriate SOPs.
• Follow SOPs, product batch record instructions, logbooks and forms, and corresponding quality documentation in detail.
• Prepare and maintain accurate documentation following cGMP and GDP principles.
• Ensure documentations are completed in real-time in accordance to CGMP and GDP principles.
• Adhere to all environmental, health, and safety policies and procedures and proactively identify unsafe conditions.
• Support QC sampling, equipment calibration, equipment/utility validation, and preventive maintenance as needed.
• Work collaboratively with internal teams to meet site goals and objectives as part of a team.
• Initiate and foster a spirit of cooperation within and between departments.
• Review documentation for accuracy, makes corrections and/or escalates to supervision/Manufacturing Quality Associate (MQA).
• Maintain all personal cGMP related training in a current state.
• Achieve and maintain cleaning and sanitization of cleanroom training. 
• Participate in Aseptic media qualification per the appropriate qualification protocol.
• Support manufacturing in the investigation of deviations and performs required risk assessments.
• Participate in personnel monitoring as requested.
• Work closely with Operational Excellence to identify and implement process improvements.
• Set up and breakdown the filling equipment per appropriate SOPs.
• Transport equipment and components as needed.
• Interact with filling machines at the validated speeds and volumes.
• Perform volume checks.
• Perform and document inherent and non-inherent interventions.
• Ensure slow and purposeful movements appropriate for a Grade A/B GMP aseptic environment.
• Work with R&D and tech transfer team for successful transfer of Programs into the GMP area
• Perform all aseptic connections, respecting first air.
• Perform pre- and post-filter integrity testing as required.
• Aseptically sterile filter products into appropriate vessels.
• Complete routine and enhanced cleaning and sanitization of all controlled aseptic cleanrooms, as needed.
• Attain and maintain ability to perform environmental tasks as required.
• Perform other duties as assigned.

Qualifications:

• High school diploma or equivalent with 1-3 years’ experience, Bachelor’s degree with a minimum of 1 year of experience, or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities.
• Prior experience in related field, preferred.
• cGMP manufacturing knowledge, preferred.
• Aseptic filling and general production knowledge, preferred.
• Demonstrate basic math skills.
• Demonstrate the ability to establish good working relationships with other departments, including vendors, colleagues, and subordinates.
• Demonstrates the appropriate technical knowledge necessary to make sound decisions on development issues with minimal supervision.
• Demonstrate the ability to analyze data and information and assess and resolve complex problems/issues as required.
• Must be able to comprehend and follow all applicable SOPs.
• Demonstrate knowledge and experience with electronic Quality Management Systems such as MasterControl and Trackwise.
• Demonstrate ability to acquire the appropriate knowledge from resources on the current federal, local, and international regulations regarding the production, testing, and release of drug substances and products.
• Good understanding of cGMPs, industry, and regulatory standards and guidelines.
• Demonstrate familiarity with Microsoft programs like Word, Excel, PowerPoint, Project, Teams, Outlook, etc.
• Demonstrate the ability to portray the appropriate level of integrity and professionalism.
• Demonstrate the ability to communicate effectively with management, staff, regulators, and client representatives in written and verbal formats.
• Demonstrate the ability to complete tasks accurately and according to established and shifting timelines.
• Demonstrate the ability to make quality scheduling, resource allocation, and priorities decisions.
• Energetic, execution-focused, self-motivated, and organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
• Results-oriented and efficient.
• Creative and open-minded who fosters an environment in which sharing of ideas is encouraged.
• Demonstrate the ability to work closely with a diverse customer and employee base (internally and externally).
• Demonstrate the ability to work well in a cross-functional team environment.
• Must communicate fluently in English and have legible handwriting.

Physical Demands:

• Ability to travel between and within facilities to visit staff, operations, and projects, as needed.
• Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary).
• Ability to lift up to 40 pounds on occasion.
• Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary).

Jabil, including its subsidiaries, is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, religion, national origin, sex, age, disability, genetic information, veteran status, or any other characteristic protected by law.

BE AWARE OF FRAUD: When applying for a job at Jabil you will be contacted via correspondence through our official job portal with a jabil.com e-mail address; direct phone call from a member of the Jabil team; or direct e-mail with a jabil.com e-mail address. Jabil does not request payments for interviews or at any other point during the hiring process. Jabil will not ask for your personal identifying information such as a social security number, birth certificate, financial institution, driver’s license number or passport information over the phone or via e-mail. If you believe you are a victim of identity theft, contact the Federal Bureau of Investigations internet crime hotline (www.ic3.gov), the Federal Trade Commission identity theft hotline (www.identitytheft.gov) and/or your local police department. Any scam job listings should be reported to whatever website it was posted in.

The hourly pay range for this role is $23.99 - $43.17. Job-related, non-discriminatory factors used to determine the actual offered rate include qualifications and experience, geographic location, education, external market data, and consideration of internal equity.

As part of the total rewards package, Jabil offers benefits to enhance your health, wealth, and resilient self. These include medical, dental, and vision insurance plans; paid time off; paid parental leave; company-paid holidays subject to change yearly; 401(k) retirement plan; and employee stock purchase plan.

Accommodation Statement

If you are a qualified individual with a disability, you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access Jabil.com/Careers site as a result of your disability. You can request a reasonable accommodation by sending an e-mail to Always_Accessible@Jabil.com or calling 727-803-7988 with the nature of your request and contact information. Please do not direct any other general employment related questions to this e-mail or phone number. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to.