Senior Packaging OperatorMechanic

Senior Packaging Operator/Mechanicwith experience inpackagingoperations and labelingrequirements for Parenteral biotechnology facilities, fill & finish, vials.
Experience in fill & finish of syringes. (Optima, IMA, among others).

Accountable for developing innovative, creative and cost competitivepackagingsolutions whichmeet the needs and requirements of our patients, our sustainability objectives and our qualitystandards.
Generate and review regulatory submission documents, plans, protocols and reports ensuringthat the project objectives are met (Design History File documentation)
Contribute and support relevant information to the Design transfer team to enable successfulpackagingtransfer manufacturing operations and/or contract laboratories
Ensure that work is performed in accordance with appropriate safety, quality and compliancestandards.
Influence understanding and interpretation ofpackagingregulations
Represent specialistpackagingarea (SME) on Device Project Teams, ensuring the provision ofappropriate data (technical, resource & budgetary)
Understand and Influence developments within the industry
Contribute to the training and development ofpackagingcolleagues by acting as coach/mentoras appropriate.

Requirements

Experience with Fill & Finish of syringes

Experience with troubleshooting..

Experience withpackagingmachines (IMA & OPTIMA)

Experience with thepackagingprocess & labeling.

Preferred experience in aseptic filling operations

Benefits

1 year contract position with expected extension.

Senior Packaging Operator/Mechanic with experience in packaging operations and labeling requirements for Parenteral biotechnology facilities, fill & finish, vials. Experience in fill & finish of syringes. (Optima, IMA, among others) Lead the development, testing, and validation of all packaging presentations for biotechnology products to achieve project targets in a timely fashion. Accountable for developing innovative, creative and cost competitive packaging solutions which meet the needs and requirements of our patients, our sustainability objectives and our quality standards. Generate and review regulatory submission documents, plans, protocols and reports ensuring that the project objectives are met (Design History File documentation) Contribute and support relevant information to the Design transfer team to enable successful packaging transfer manufacturing operations and/or contract laboratories Ensure that work is performed in accordance with appropriate safety, quality and compliance standards. Influence understanding and interpretation of packaging regulations Represent specialist packaging area (SME) on Device Project Teams, ensuring the provision of appropriate data (technical, resource & budgetary) Understand and Influence developments within the industry Contribute to the training and development of packaging colleagues by acting as coach/mentor as appropriate. Requirements Experience with Fill & Finish of syringes Experience with troubleshooting.. Experience with packaging machines (IMA & OPTIMA) Experience with the packaging process & labeling. Preferred experience in aseptic filling operations