Senior Packager, Pilot

Edwards Lifesciences; Irvine (CA); On-site; USD 45,000 - 62,000; Full time

Job summary

Edwards Lifesciences is seeking a Senior Packager to support packaging (THV) activities in our California manufacturing environment. You will ensure quality and compliance across labeling, packaging, and warehouse return processing, working closely with manufacturing and QA teams.

Responsibilities include line clearance, peel-testing, and accurate documentation in device history records and JDE, with a focus on detail and adherence to SOPs. Strong English communication required.

Qualifications

• 4 years related experience including GMP, clean room and medical device experience.
• Must be able to read, comprehend, write, and speak English, including giving and receiving feedback.

Responsibilities

• Inspect labels and packaging to ensure quality, regulatory and SOP standards are met; perform outer and inner packaging at a mastered level.
• Package products, generate labels, and apply labels on packaging; re-labeling and packaging of warehouse returns and NCR repairs.
• Perform line clearance by cleaning and sanitizing work stations at shift start and when transitioning to next orders; ensure components and tools are ready for the build.
• Perform integrity peel-testing of inside packaging pouch.
• Follow and perform job functions per work instructions and SOPs; record traceable information on device history records and enter data into JDE.
• Palletize product for outside sterilization services and ensure drawings followed and Biological Indicators placed per SOPs.

Skills

GMP experience

Clean room

Packaging operations

Documentation

Education

HS Diploma or equivalent

Tools

JDE

Job description

Imagine how your ideas and expertise can change a patient’s life. Our Global Operations & Quality team plays a central part in ensuring our products are delivered to patients with cardiovascular disease. You’ll partner cross-functionally with manufacturing operations and sales teams, delivering thoughtful solutions to complex challenges all while developing your knowledge of the medical device industry. Whether your work includes strategic inventory planning, labeling, warehouse management, material handling, or any of our other supply chain opportunities, you will be making a meaningful contribution to our team and to patients all over the world.

Make a meaningful difference to patients around the world. At Edwards Lifesciences facilities around the world, our Manufacturing teams create the tools, technologies, and devices that transform patients’ lives. As part of our sewing, assembly, delivery, and distribution teams, your attention to detail and commitment to continuous improvement will help us turn innovative ideas into reality. Your purpose-driven work will help leave lasting and positive impacts on patient lives.

The Senior Packager performs packaging (THV) work to support manufacturing/production activities, following established procedures and guidance.

How you’ll make an impact

• Inspect labels and packaging to ensure quality, regulatory and SOP standards are strictly met. Perform both outer and inside packaging procedures, at a fully mastered level while working independently at the highest levels of quality and productivity.


• Package products, generate labels, and place labels on packaging, in strict keeping with quality, regulatory and SOP standard as well as perform re-labeling and packaging of warehouse returns and NCR repairs.


• Perform line clearance, i.e., cleaning and sanitizing work stations at the start of the shift and when transitioning to next work orders. Ensure all required components and tools are ready for the build.


• Perform integrity peel-testing of inside packaging pouch.


• Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records and may enter information into JDE (issuing packaging materials from floor stock inventory).


• Palletize product to send to outside sterilization services, ensuring drawings are followed and that Biological Indicators are placed correctly per SOPs.

What you’ll need (Required)

• 4 years related experience required including GMP, clean room, medical device experience.


• Due to the specific duties of this job, you must be able to read, comprehend, write, and speak English, including giving and receiving feedback.

What else we look for (Preferred)

• H.S. Diploma or equivalent.


• Adhere to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing.


• Proven ability to complete, retain, and incorporate training coursework in the performance of new and advanced work procedures.


• Must be able to work with minimum supervision by following detailed manufacturing instructions as well as work in a Team environment, primarily work with colleagues and supervisor and may also work on inter-departmental teams.


• Strict attendance to detail and ability to comply with standards.


• Ability to perform all packaging operations.


• Full understanding of manufacturing procedures and pouch peel-test integrity operations.


• Good computer skills required with in-depth understanding of documentation and JDE transactions.


• Provide training, and may provide coaching to more junior employees. Evaluate and demonstrate correct approach on work of other employees, in the absence of the Lead.


• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control.

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California (CA), the base pay range for this position is $45,000 to $62,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.