Manufacturing Technician - Bio

Job Description

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.