Validation Engineer, Operations

Our client is a global biopharmaceutical company located near Neuchatel, Switzerland

Focused on research, development, and delivery of innovative medicines across several therapeutic areas, including oncology, hematology, immunology, and cardiovascular disease

The Role

To perform validation and qualification activities in compliance with cGMP as well as internal policies and procedures. Will be authorized to direct external vendors performing work in this field.

Responsibilities:

May be assigned Qualification/Validation Lead role for a defined validation/qualification area

Develop and justify the validation approach based on risk and scientific rationale

Ensure equipment and systems are qualified, validated and maintained in compliance with local policies, guidelines, and procedures during their lifecycle

Author and when required review validated documents, including requirement specifications, qualification/validation plans, protocols, reports, traceability matrix and summary reports.

Execute qualifications/validations or manage people with the role of tester (including vendors) for all equipment and systems across the site, including QC, warehouse, facilities, lab equipment, utilities and computer system validation, excluding global IT systems.

Define and execute periodic activities maintaining qualified/Validated states of equipment, analytical instruments, utilities & facilities and computerized system

Contribute to the development and maintenance of the local site procedures

Ensure the Validation strategy on-site fit with global validation strategy in collaboration with global team

Lead risk assessments and risk management teams

Review/assess change controls and maintenance interventions, evaluating the impact upon qualified systems & validated processes, and documents required actions

Coordinate qualification and validation execution activities, including external vendors and internal departments.

Supervise internal and external resources dedicated for project.

Leads new hire process for additional validation activities

Participate in internal and external audits as SME, by answering questions, reviewing qualifications and validations with auditors, and providing documentation.

Establish and maintain effective relationships with internal team, customers and suppliers.

Contribute to continuous improvement, including proactively identifying problems and proposing solutions

Autonomous; completes work independently, seeking guidance on complex tasks and nonroutine decisions

Participates in projects and initiatives as directed by their leader

You

Our client is looking for someone with the following qualifications/competencies:

BS/MS in Engineering/Technical discipline or equivalent experience

3-5 years experience in pharmaceutical Validation

Strong knowledge of current international regulatory regulations, cGxP requirements and best practices, including 21 CFR part 11, 210 and 211, Annex 11, EU-GMP guidelines and GAMP

Good ALCOA & Data Integrity knowledge

Knowledge of pharmaceutical facilities (including HVAC and utilities), manufacturing and laboratory equipment/systems and computerized system validation (CSV)

Communicate pro-actively and collaboratively

Proactively identify problems and recommend solutions

Team player: ability to interact

Proactively identifies problems and recommends solutions Team player: ability to interact effectively with team and customers

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