CSV Validation Engineer

CSV Validation Engineer - Bern 

We are actively hiring for a talented CSV Engineer to be based in Bern, for a 12 month contract.

ESSENTIAL:

• Johnson & Johnson CSV Engineer

• 12 months contract 

• 2 years + CSV, Validation experience 

• English essential, German preferred 

• 2 years of working experience within pharma or a biotech company

• Know-how of CSV requirements according to FDA 21CFR part 11/ EUGMP Annex 11 regulations and ISPE GAMP 5 guidelines

Start Date - Jan 2023 

The Company:

Johnson & Johnson is the world's most comprehensive and broadly-based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical and medical devices & diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.

The Role:

In charge of Computer System Validation (CSV) activities for Technical Services department in order to ensure that: 

• Validation phases are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities

• Validation Master plans are up to date and established for all ongoing projects

Essential duties

· Assess and lead specific assigned CSV package(s) on project Hercules taking accountability for the work to be produced by yourself and other colleagues that are under the assigned packages lead by this position.

· Hands on: Plan, coordinate and execute all phases for computer system validation of production and QC Lab systems including but not limited to, Validation plans, FMEA, RTM, DQ, IQ, OQ, PQ test scripts.

· Prepare, review, and approve technical and GMP related documentation (URS, impact/risk assessment, Master plans, qualification/validation documentation)

· Understand customer needs and define electronic records requirements for computerized system adhering to regulation and company standards

· Coordinate and execute FAT/SAT, commissioning activities focused on CSV for new systems in collaboration with internal and external partners

· Validation planning for base business including interaction with IT, Maintenance Automation and Quality Operations groups

· Coordination and oversight of external subcontractors / software suppliers

· Operational handling of Change Controls, CAPAs and Non-Conformances related to CSV

· Support Technical Services department KPI.

· Ensure the CSV process related procedures and life cycle management are up to date according to international GMP standards and internal procedures

· Contribute to ensure that changes introduced in the organization of systems, procedures, processes and formulas are managed so that all aspects of the equipment / computerized systems commissioning, and qualification process are assessed and resolved.

Essential

· Bachelor/masters degree in technical or natural sciences

· Ability to work in a fast-changing environment

· A minimum of 3 years of working experience within pharma or a biotech company

· Experience on validating computerized manufacturing equipment (CSV context)

· Experience on validating software & hardware infrastructure (e-g: servers, network and software services).

· A minimum of 4 years of working experience with CSV

· Know-how of CSV requirements according to FDA 21CFR part 11/ EUGMP Annex 11 regulations and ISPE GAMP 5 guidelines

· Excellent communication skills

· Analytical thinking and problem-solving ability

· Ability to work under minimal supervision; Assess priorities and work well under pressure in a fast-paced environment

· Ability to effectively work as part of a multidisciplinary, international team

· Business fluency in English

Preferred

· German language

· Experience on validating complex computerized analytical equipment

· Basic know-how of Qualification requirements according to cGMP regulations

· Basic know-how of quality assurance principles

 We are looking to process the first round of applications within the next 2 working days.

Thank you very much and we look forward to receiving your application. 

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.

That is why we are working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feel that they belong and can reach their potential. No matter who they are.

Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!