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Technical Operations Engineer Process &

Technical Operations Engineer Process and Cleaning Validation

Locations: Beerse, Belgium
Functions: Quality (Eng)
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Job Description

Requisition ID: 1905722396W

Within the local Beerse Technical Operations Department of the Janssen Supply Chain Organization, the Technical Operations Team is responsible for validation of cleaning recipes and manufacturing processes in the JSC organizations.

The mission of the organization is to ensure that the validation is executed and documented according to the current quality and compliance standards based on the critical quality attributes and process parameters in order to meet the specifications with acceptable degree of confidence and also to meet business requirements.

To support the professional deployment of these Validation activities throughout the Supply Chain organization of Beerse, Janssen is looking for a new

Technical Operations Engineer Process & Cleaning Validation for commercial manufacturing
Purpose of the function:

As a validation engineer you will be responsible for process and cleaning validation and optimization and ensure compliance to the international regulations and guidelines.
Your Responsibilities:
* You are responsible for maintaining the process validation status of pharmaceutical products in commercial manufacturing.
* You are responsible for maintaining the cleaning validation status of equipment used in the JSC manufacturing areas.
* You coordinate and perform validation/revalidation of manufacturing processes and cleaning processes related to introduction of new products/product transfers, triggered by changes to the manufacturing process or equipment or resulting from APR/PCQR.
* You issue, review and approve validation documents such as validation plans, protocols, reports, master documents, rationales, statements, SOPs, cleaning recipes,... in order to maintain compliance to regulations, guidelines, J&J policies and standards.
* You act as Subject Matter Expert for validation related topics for change control and deviation handling.
* You maintain a current knowledge of international regulations, guidelines and new evolutions related to validation topics through courses, conferences, seminars, internal and external benchmarking and literature studies. Implement this knowledge to maintain and improve Validation standards at Janssen.
* You prepare for regulatory and customer audits and inspections. You are the spokesperson for validation related matters during audits and inspections.
* You are part of tech transfer teams and interact with other groups for the introduction of new products and new systems and processes. You give advice and support for the preparation of validation related activities and guard the cGMP aspects in new projects. You are a member of cross-functional teams to realize cross-departmental objectives.

You perform Periodic Cleaning Quality Reviews (PCQR) to define the need for optimization/revalidation of the cleaning processes. You participate in Annual Product Review (APR) and Continued Process Verification (CPV).

Qualifications
Your Qualifications:
* You have a Master degree in technical/chemical area or similar.
* A 3 plus years of comprehensive experience within the pharmaceutical environment is required.
* Strong working experience in regulatory controlled environment: 21 CFR Parts 210, 211; EU Directive 2003/94/EC and annexes is also required.
* You have demonstrated experience in writing and managing compliance documentation.
* You have excellent verbal and written communication skills. You are fluent in Dutch & English (written and spoken).
* You possess the credibility and experience to act as subject matter expert during internal audits and external regulatory inspections.
* Experience and understanding of audit readiness and management is required.
* You have strong influencing and negotiation skills.
* You have strong collaboration and teaming skills.

Primary Location
Belgium-Antwerp-Beerse-
Organization
Janssen Pharmaceutica N.V. (7555)
Job Function
Quality (Eng)
Requisition ID
1905722396W

Technical Operations Engineer Process &

Permanent contract
Engineering, Chemical Engineer, Chemical Engineer, Manager, Technical