Manufacturing Associate I - Packaging
6701 Kaiser Drive Fremont, CA 94555 US
*Depending on experience
Executes routine unit operations in Manufacturing Assembly and Packaging as assigned related to the manufacturing of drug product in a multi-product facility. Performs duties under limited supervision and according to standard operating and manufacturing procedures.
This position is responsible for assisting the Sr. Associate and Master Associate in performing assembly and packaging in designated functional manufacturing area. Support with troubleshooting to equipment.
As an employee, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect high regard for our employees.
Duties & Responsibilities:
• Assists in the setup of the automated autoinjector assembly machine, pre-filled syringe assembly machine and semi-automated tabletop machine. This assistance includes tasks such as gathering tools, machine parts and documents required for such activities. Retrieves components and equipment from storage
• Assists with the equipment changeover
• Assists with minor equipment repairs/adjustments
• Assists with real-time identification and correction of problems. Problems may include, but are not limited to mechanical issues, component issues
• Performs all work in accordance with Company Policies and Procedures. All work is documented in controlled documents (batch records, logbooks or SOP attachments) in accordance with SOP. All activities are to be documented in the batch record. All events are to be recorded in the batch record and brought to the attention of the production supervisor for further action.
• Assists with room cleaning in production areas. Will transfer rubbish to the transfer zones and may empty transfer zones of rubbish when required. This includes removal of equipment, room sanitization and disposal of waste according to established safety requirements
• Responsible for following controlled documents to ensure that the equipment identified for operations are used and documented. This includes verification of equipment calibration. Completes logbooks, as required.
• Responsible for performing assembly and packaging operations and assisting in visual inspection/filling operations, if required.
• Ensures components, materials and supplies are stocked prior to the start of the assembly and packaging operations
• Movement of product and components within the assembly and packaging area
• Transfer product, components and equipment within the CNC area.
• Communication and hand-off to relief personnel during shift change as appropriate
• Maintains production areas according to predefined standards (5s)
• Adheres to safety standards, identifies unsafe situation / habit and escalates appropriately
• High School degree plus minimum one (1) year work experience in GMP regulated industry
• Associate/Bachelor degree from an accredited institution or biotechnology vocational training preferred
• Demonstrated ability to be organized and work well in small work groups.
• Demonstrated mathematical skills, including the ability to perform addition, subtraction, multiplication, division, and conversions.
• Detail oriented. Demonstrated ability to read, comprehend, and follow written instructions.
• Demonstrated written and verbal communication skills are required.
• Must be able to work in a team environment.
• Experiences in related GMP environment within biotechnology/pharmaceutical industry strongly preferred
• Must be able to learn and perform basic computer operations such as MS Office and Outlook and other computer based software
• Physical Demands / Surroundings - Requires physical activity such as almost constant standing, walking. Works regularly under desirable conditions with some moderately disagreeable conditions in the manufacturing setting
• Temperaments/Mental Requirements - The position requires concentration as errors might cause minor to moderate delays, confusion, or expense to correct. The position has some contact with other departments and the associate must be able to discuss issues and ideas with an open mind and even temper.
• Level of Proficiency - Entry level in subject matter
• Attendance / Schedule - The schedule is dependent on the shift for which the associate is hired. Attendance requirements are based on general attendance policies.
• To remain in this position, employees:
• Must obtain & maintain qualifications, as required, to perform the assigned work.
• Must understand, will be held accountable for and must adhere to all SOPs, company Policies and Procedures
• Must adhere to proper technique, proper documentation practices, and all other aspects of the cGMP’s
Must be legally authorized to work in the United States without restriction.
Must be willing to take a drug test and post-offer physical (if required)
Must be 18 years of age or older
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.