Mfg Process Technician

Under general supervision, the Manufacturing Process Technician will routinely perform simple to moderately-complex processes according to Standard Operating Procedure and Batch Records. Generally, this will include all aspects associated with bulk manufacturing in aseptic and non-aseptic environments.

Responsibilities:

• Strict adherence to current Good Manufacturing Practices (cGMP's), the ability to accurately complete process-associated documentation, make calculations and perform the tasks associated with Manual Visual Inspection and other Fill/Finish duties as assigned.
• Follow all applicable safety procedures
• Written and oral communication skills. Proficiency in reading and writing English.
• Ability to perform basic computer operations, such as ability to navigate in MS Office, use email, and complete training using Computer Based Training (CBT).
• Ability and willingness to work any day, swing, or grave shift in support of operations.
• Specific responsibilities include: manual visual inspection and packaging of product-filled containers per procedures and batch records
• Setting up and operating equipment and assisting or participating in other manufacturing operations
• Performing internal support operations (e.g. stocking items, tracking inventory, material movement)
• Recognizing and reporting malfunctions and troubleshooting/adjusting to equipment per procedure and/or training.
• Ability to comprehend, follow and document batch records for the inspection and process using Good Documentation Practices (GDPs)
• Reconcile components and products, and calculate product exposure to room temperature
• Working conditions involve repetitive use of hands, arms and eyes and require exposure to cold rooms and freezers

Basic Qualifications:

Associate's degree & 2 years of Manufacturing & Operations experience

OR
High school diploma/GED & 4 years of Manufacturing & Operations experience

Preferred Qualifications:

• Ability to perform basic computer operations, such as ability to navigate in MS Office, use email, and complete training using Computer Based Training (CBT).
• Ability and willingness to work any shift in support of operations that may include non-standard shift
• Proficiency in reading and writing English
• Experience in GMP or other regulated environment
• Organizational skills and an ability to perform assignments with a high degree of attention to detail
• Capacity to follow written procedures, recognize and report malfunctions and make adjustments to equipment.
• Documentation skills
• Written and oral communication skills
• Knowledge in Manual Visual Inspection
• 1+ years of work experience that involves the use of measurements calculations and the metric system
• Adhere to current Good Manufacturing Practices, cGMPs and follow Standard Operating Procedures SOPs, Batch Records and departmental policies
• Ability to assemble, disassemble and perform basic troubleshooting on simple to moderately complex equipment, per procedures
• Excellent written and verbal communication skills with the ability to effectively communicate thoughts and ideas
• Ability to work independently as well as on teams
• Ability to prioritize tasks and work in a challenging and fast-paced work environment
• Ability to interpret and apply regulatory and quality requirements

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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