We are seeking a skilled Manufacturing Specialist to join our team, focusing on the critical aspects of our aseptic manufacturing process. This role is integral to ensuring the efficient and compliant operation of our biologic manufacturing process. The Manufacturing Specialist will handle the preparation, filtration, and filling of various pharma products.
Key Responsibilities:
Training & Compliance: Complete and uphold aseptic qualification training and maintain an understanding of relevant tasks, operations, and documentation with guidance from senior team members.
Documentation Management: Diligently follow standard operating procedures (SOPs), batch records, and quality assurance documentation, ensuring all records are accurate and updated in real-time according to cGMP standards.
Safety & Quality: Adhere to all health, safety, and environmental regulations while actively identifying and addressing potential hazards.
Quality Control Support: Assist with quality control sampling, equipment calibration, and validation processes as required.
Team Collaboration: Work closely with cross-functional teams to achieve production goals and foster a collaborative work environment.
Documentation Review: Review and verify documentation accuracy, making necessary corrections or escalating issues as needed.
Training Maintenance: Keep all personal training related to cGMP protocols up to date and participate in cleaning and sanitation training for clean room environments.
Process Improvement: Collaborate with the Operational Excellence team to identify and implement process enhancements.
Equipment Management: Set up and dismantle filling equipment according to established procedures, ensuring operational efficiency.
Filling Operations: Operate filling machinery at validated speeds, perform volume checks, and execute necessary interventions with precision in a Grade A/B environment.
Aseptic Techniques: Execute aseptic connections with care, perform pre- and post-filter integrity tests, and ensure products are filtered into appropriate containers under sterile conditions.
Cleaning Protocols: Carry out routine and enhanced cleaning procedures in all controlled aseptic areas, maintaining high cleanliness standards.
Qualification
High school diploma or equivalent with 3 years experience
Bachelor's degree with a minimum of 1-2 year of experience