Position Overview:
We are seeking a motivated Biologics Manufacturing Technician to support the production of biologic products within our state-of-the-art manufacturing facilities. The successful candidate will be responsible for performing downstream processing operations in compliance with current Good Manufacturing Practices (cGMP). This role requires precision, attention to detail, and the ability to work effectively in a cleanroom environment under supervision. You do not need prior experience and can be a recent graduate in life sciences.
This is a 2nd shift position
Schedule: M-F 3 pm to 11:30 pm
Key Responsibilities:
- Assist in the preparation of instruments and execution of downstream purification processes in a cleanroom setting, adhering to cGMP standards.
- Follow detailed instructions provided in GMP documents, including Standard Operating Procedures (SOP) and Master Batch Records (MBR).
- Communicate progress and escalate issues as necessary to supervisors; document activities, deviations, and variances that occur during production.
- Participate in investigations of deviations and contribute to the implementation of Corrective and Preventive Actions (CAPAs).
- Perform regular cleaning and maintenance in the cleanroom environment, including surface, periodic, and changeover cleaning, in line with cGMP requirements.
- Collaborate with Supply Chain and Engineering teams to assist in equipment validation, calibration, and maintenance tasks.
- Utilize support systems such as Laboratory Information Management Systems (LIMS) during the production process.
- Ensure all tasks are performed in accordance with regulatory guidelines, international standards, and company policies.
- Practice and promote safe working habits, following all safety protocols and company procedures.
Qualifications:
- High School Diploma or GED required; a college degree is preferred.
- Previous experience in the pharmaceutical or biologics manufacturing industry is a plus.
- Familiarity with bulk biologics production and cGMP manufacturing processes is preferred.
- Experience working with TFF (Tangential Flow Filtration) skids, centrifuges, chromatography columns and systems, and/or UF/DF (Ultrafiltration/Diafiltration) systems is advantageous.
- Strong communication skills and ability to collaborate effectively with internal teams, vendors, and clients.