Packaging Engineer
Scope of work includes all commercial products in the Oncology, Small Molecule portfolio, packaged within the internal Packaging Network and approved contract manufacturing organizations (CMO's).
You will function as an individual contributor to managing ALL/ANY LEO impacted changes for the group in US, EU and other markets from the portfolio.
This role is to support the CMO Packaging Engineering and may include projects/product supplied both from internal and external CMO operations.
Responsibilities:
You will manage all the documentation requirements of Packaging Engineers to facilitate Legal Entity Organization, MAH changes resulting from the Integration of multiple acquired organizations and products.
Support team in substantiating and qualifying alternate component substrates, suppliers, and processes to mitigate risk of supply The development (input), launch, life cycle management and continuous improvement Lead or own change control, non-conformances and CAPA activities working with Quality and Global Labeling Operations Manage implementation of platform (harmonization / standardization) components Manage bill of materials, etc.
You will facilitate template inclusion of regulatory (serialization) and global corporate standard labeling requirements (i.
e.
authentication) Profile:
cGMP SME in packaging Technical specification, profile drawing development (Auto Cad, etc.
) Specification development, review, approval and implementation Trackwise (change control, deviation/investigation and CAPA initiation, review and approval mechanisms a must) Requirements:
Bachelor's Degree in an engineering related field (Packaging Engineering preferred) 5 years pharmaceutical experience (or equivalent) Strong knowledge of cGMP documentation Strong technical, interpersonal, communication and leadership skills.
Knowledge of electronic documentation systems (MUST:
Trackwise) Demonstrated organizational skills including project management With over 90 years' combined experience, NES Fircroft (NES) is proud to be the world's leading engineering staffing provider spanning the Oil & Gas, Power & Renewables, Chemicals, Construction & Infrastructure, Life Sciences, Mining and Manufacturing sectors worldwide.
With more than 80 offices in 45 countries, we are able to provide our clients with the engineering and technical expertise they need, wherever and whenever it is needed.
We offer contractors far more than a traditional recruitment service, supporting with everything from securing visas and work permits, to providing market-leading benefits packages and accommodation, ensuring they are safely and compliantly able to support our clients.
Recommended Skills Business Process Improvement Communication Coordinating Electronics Leadership Oncology Estimated Salary: $20 to $28 per hour based on qualifications.
You will function as an individual contributor to managing ALL/ANY LEO impacted changes for the group in US, EU and other markets from the portfolio.
This role is to support the CMO Packaging Engineering and may include projects/product supplied both from internal and external CMO operations.
Responsibilities:
You will manage all the documentation requirements of Packaging Engineers to facilitate Legal Entity Organization, MAH changes resulting from the Integration of multiple acquired organizations and products.
Support team in substantiating and qualifying alternate component substrates, suppliers, and processes to mitigate risk of supply The development (input), launch, life cycle management and continuous improvement Lead or own change control, non-conformances and CAPA activities working with Quality and Global Labeling Operations Manage implementation of platform (harmonization / standardization) components Manage bill of materials, etc.
You will facilitate template inclusion of regulatory (serialization) and global corporate standard labeling requirements (i.
e.
authentication) Profile:
cGMP SME in packaging Technical specification, profile drawing development (Auto Cad, etc.
) Specification development, review, approval and implementation Trackwise (change control, deviation/investigation and CAPA initiation, review and approval mechanisms a must) Requirements:
Bachelor's Degree in an engineering related field (Packaging Engineering preferred) 5 years pharmaceutical experience (or equivalent) Strong knowledge of cGMP documentation Strong technical, interpersonal, communication and leadership skills.
Knowledge of electronic documentation systems (MUST:
Trackwise) Demonstrated organizational skills including project management With over 90 years' combined experience, NES Fircroft (NES) is proud to be the world's leading engineering staffing provider spanning the Oil & Gas, Power & Renewables, Chemicals, Construction & Infrastructure, Life Sciences, Mining and Manufacturing sectors worldwide.
With more than 80 offices in 45 countries, we are able to provide our clients with the engineering and technical expertise they need, wherever and whenever it is needed.
We offer contractors far more than a traditional recruitment service, supporting with everything from securing visas and work permits, to providing market-leading benefits packages and accommodation, ensuring they are safely and compliantly able to support our clients.
Recommended Skills Business Process Improvement Communication Coordinating Electronics Leadership Oncology Estimated Salary: $20 to $28 per hour based on qualifications.
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