Senior Validation Engineer-00000QDL
Description
Cilag AG is a successful international Development- and Manufacturing Facility in the Pharmaceutical Sector of Johnson & Johnson, located in Schaffhausen, Switzerland.
Our Qualification and Validation Department is responsible for the security, implementation and monitoring of Qualification- and Validation requirements as well as the general Quality specifications for our Pharma- and Chemical production. Within our Site Validation Group we are currently looking for an experienced Senior Validation Engineer to be based in Schaffhausen, Switzerland.
POSITION SUMMARY:
As a Senior Validation Engineer you will be accountable for the validation of manufacturing and packaging processes of new product introductions, technology transfers and legacy non-biologic and biologic parenteral liquid and lyophilized products filled in syringes and vials as well as tablets and capsules filled into bottles and blisters. As a Senior Validation Engineer you will also represent the site Qualification/Validation group on cross functional teams responsible for the development and delivery of Parenterals and Solids Platform strategic projects as well as key compliance initiatives for the Janssen Supply Chain.
PRINCIPAL AREA OF RESPONSIBILITIES:
- Qualification/Validation Site Lead for New Product Introductions and Technology Transfers
- Validation Life Cycle Management Product Owner
- Validate Manufacturing and Packaging Processes
- Provide Technical Assessments to Change Controls/CAPA’s and Deviations
- Own and Coordinate Qualification/Validation Activities with Internal, Cross Platform, Cross Sector and External Partners
Qualifications
PROFILE:
For this responsible position we are looking for an innovative team player with thorough understanding of business requirements that has the ability to effectively represent the Qualification/Validation Group in cross-functional and cross-sites teams within a complex global matrix organization with multiple stakeholders.
The following hard skills are required/ preferred:
- a University/Master Degree in Chemistry, Pharmacy or Engineering with a minimum of 4 years related experience in the pharmaceutical sector preferred or expertise in the packaging industry, with past proven field experience in some or more of the following areas:
- Experience in Solids and/or Parenteral Manufacturing and/or Packaging Process
- Technology Transfer
- Validation
- Knowledge of Quality Assurance and Regulatory Compliance cGMP and EH&S
- Strong decision making and problem solving competencies
- Fluent in English, German is a plus
We are offering you a multifaceted challenge in a dynamic, international environment with attractive terms and career opportunities as well as a good infrastructure.
If you are interested in this position, then please apply online including application letter, CV and ideally testimonials.
J2W: JOBSCH
Primary Location:Europe/Middle East/Africa-Switzerland-Schaffhausen
Organization: Cilag AG (8562)
Job Function: Validation
Description
Cilag AG is a successful international Development- and Manufacturing Facility in the Pharmaceutical Sector of Johnson & Johnson, located in Schaffhausen, Switzerland.
Our Qualification and Validation Department is responsible for the security, implementation and monitoring of Qualification- and Validation requirements as well as the general Quality specifications for our Pharma- and Chemical production. Within our Site Validation Group we are currently looking for an experienced Senior Validation Engineer to be based in Schaffhausen, Switzerland.
POSITION SUMMARY:
As a Senior Validation Engineer you will be accountable for the validation of manufacturing and packaging processes of new product introductions, technology transfers and legacy non-biologic and biologic parenteral liquid and lyophilized products filled in syringes and vials as well as tablets and capsules filled into bottles and blisters. As a Senior Validation Engineer you will also represent the site Qualification/Validation group on cross functional teams responsible for the development and delivery of Parenterals and Solids Platform strategic projects as well as key compliance initiatives for the Janssen Supply Chain.
PRINCIPAL AREA OF RESPONSIBILITIES:
- Qualification/Validation Site Lead for New Product Introductions and Technology Transfers
- Validation Life Cycle Management Product Owner
- Validate Manufacturing and Packaging Processes
- Provide Technical Assessments to Change Controls/CAPA’s and Deviations
- Own and Coordinate Qualification/Validation Activities with Internal, Cross Platform, Cross Sector and External Partners
Qualifications
PROFILE:
For this responsible position we are looking for an innovative team player with thorough understanding of business requirements that has the ability to effectively represent the Qualification/Validation Group in cross-functional and cross-sites teams within a complex global matrix organization with multiple stakeholders.
The following hard skills are required/ preferred:
- a University/Master Degree in Chemistry, Pharmacy or Engineering with a minimum of 4 years related experience in the pharmaceutical sector preferred or expertise in the packaging industry, with past proven field experience in some or more of the following areas:
- Experience in Solids and/or Parenteral Manufacturing and/or Packaging Process
- Technology Transfer
- Validation
- Knowledge of Quality Assurance and Regulatory Compliance cGMP and EH&S
- Strong decision making and problem solving competencies
- Fluent in English, German is a plus
We are offering you a multifaceted challenge in a dynamic, international environment with attractive terms and career opportunities as well as a good infrastructure.
If you are interested in this position, then please apply online including application letter, CV and ideally testimonials.
J2W: JOBSCH
Primary Location:Europe/Middle East/Africa-Switzerland-Schaffhausen
Organization: Cilag AG (8562)
Job Function: Validation