Manufacturing Technician - Bio
Job Description
SHIFT - 1 - WED - SAT 10PM - 8AM. -
SHIFT -2 - SUN-WEDS 10PM - 8AM.
ONSITE POSITION
I. Department Overview:
• The Manufacturing department is responsible for the execution of clinical and commercial manufacturing in accordance with regulatory, site, and client requirements. Manufacturing cGMP production activities include solution preparation, master/working cell bank production, upstream cell culture, • downstream protein purification, mRNA and molecular therapeutics production, and small-scale fill/finish. Further, manufacturing operations is tasked to utilize continuous improvement methodologies to realize process optimization, efficiency gains, and waste reduction to maximize capacity outputs.
II. Specific Duties, Activities, and Responsibilities:
• This position is an entry-level position in the Manufacturing team and is the starting point to acquiring the skills and training required for a cGMP biomanufacturing environment.
• The Technician is responsible for the manufacture of biopharmaceutical products within a clean room environment.
• The position is expected to follow detailed instructions and established procedures with frequent supervision.
The Technician
• Accurately follows manufacturing Batch Production Records (BPRs) and Standard Operating Procedures
(SOPs) in accordance with current Good Manufacturing Practices (cGMPs) and with a focus on “right first-time” execution.
• documents all activities in accordance with Good Documentation Practices (GDPs) in BPRs, Forms, and other quality documentation.
• recognizes deviations from the intended procedure and raises awareness through the Rapid Response process.
• proactively identifies safety, quality, and efficiency improvements.
• actively participates in the Catalent Way (Continuous Improvement Culture).
• may lead “Just Do It” (JDI) Continuous Improvement activities and implement CI projects.
• may coach more junior team members on basic execution activities and act as an “onboarding buddy” to bring new team members up to speed on culture and basic workplace expectations.
• participates in daily shift huddles and may lead shift exchange activities.
• performs general cleanroom housekeeping, including room and equipment cleaning, disposal of waste, and maintenance of 5S standards.
• completes all training activities required to maintain quality compliance within expected milestones.
Biomanufacturing – Central Services
• performs basic buffer preparation activities, including weighing raw materials for production.
Education/Experience:
Central Services
• High School Diploma.
Behavioral Requirements:
• Ability to see and hear and read and write clear English.
• Ability to communicate effectively and follow/retain detailed written and verbal instruction in an accurate, timely, safe, and professional manner with supervisor, group members, and other departments as necessary.
• Ability to manage time effectively to complete assignments in expected time frame and independently seek out additional work when tasks are completed ahead of time.
• Ability to cooperate with coworkers within an organized team environment or work alone.
• Detail oriented and well organized with ability to work effectively under high pressure with multiple deadlines.
• Ability to put aside personal opinions and focus on business needs, department needs or group needs.
