Validation Officer/Validierungsingenieur in Herrenberg bei Perrigo

Übersicht der Beschreibung

Verantwortungsbereich der Funktion

Perrigo Company is dedicated to making lives better by bringing Quality, Affordable Self-care products that consumers trust everywhere they are sold. Help us do it.

We are looking for a Validation Officer (m/w/d) for our offices in Herrenberg

Overview of role

You will prepare and execute validation protocols according to Validation master plans and schedules incorporating Process Validation (including manufacturing and packaging process, Performance Qualification, product hold time as appropriate), Cleaning Validation, Computer Systems Validation, Spreadsheet Validation and other facility validation activities.

You will collaborate with the Engineering department on equipment qualification activities and carry out periodic lifecycle reviews for each of the validation disciplines. In addition you will support improvement projects with technical input and participating in problem solving teams (e.g CAPA, Quality Event / Deviation investigations, Kaizen etc).

Validation

• Generate and assist in the completion of qualification and validation protocols to enable the compliant and efficient introduction of new or changed products, processes, equipment, computer systems, spreadsheets and cleaning procedures.
• Report results and findings following execution of protocols.
• Conduct lifecycle reviews for products/processes, cleaning processes, computer systems, spreadsheets and other facility validation activities

Process Improvement

• Work in collaboration with other site stakeholders to provide validation and qualification expertise in improvement initiatives. Provide data via validations to support product / risk assessment processes.
• Take an active role in CAPA action teams, Deviation investigation teams and Kaizen events where required.

Risk Assessment

• Identify via risk assessment, validation and qualification requirements for both new and for changes to existing products, processes, equipment, cleaning procedures, computer systems and spreadsheets.

Other

• To undertake such other reasonable duties as may be required from time to time in order to support the Perrigo business.

Erfahrung erforderlich

• Degree as B. Sc / B. Eng. / Dipl-Ing. or comparable.
• Minimum of 2 years’ experience of validation or process engineering roles in the pharmaceutical or other regulated industry
• Ideally experience of working in an environment employing some elements of lean management, but not essential
• Knowledge of GMP and its application in validation and change management and improvement processes, ability to learn new regulations
• Flexibility to work varied hours as needed – although it is not envisaged that this will be a regular or frequent occurrence.
• Fluency in English and German
• Proficient use of MS Office