Job Description

A fantastic opportunity has arisen for a Computer Validation (CSV) Engineer. This role is responsible for the planning and execution of the computer systems validation strategies for computer and automation systems associated with the process, facility, utilities, equipment and enterprise systems in compliance to all relevant cGMP regulations, GAMP standards and company policies and procedures.

Bring energy, knowledge, innovation to carry out the following:

• Execute computer system validation activities as part of the facility design, build and qualification, including ongoing operations to maintain the validated state.
• Execute computer system validation activities for life cycle approach in accordance with good automation practices, DQ, IQ, OQ, PQ and PV following validation plans and complying with cGMP and company procedures.
• Apply 21 CFR Part 11, Annex 11 and GAMP requirements to the qualification and validation of computerised systems.
• Drafting of validation protocols and finalization of validation reports.
• Maintenance and updating of validation procedures associated with site computer system validation to maintain compliance with regulatory requirements.
• Authorship, review and approval of testing protocols and reports.
• Responsible for project delivery, vendor enquires and the troubleshooting and monitoring of process systems.
• Participate on project teams through all phases of projects - conceptual and detailed design, equipment procurement, construction, installation, start up, commissioning and qualification, and system release.
• Responsible for initiation and completion of deviations, CAPAs, and change controls for process systems including investigations relating to equipment or process performance.
• Ensure that new process systems are included in the plant maintenance and requalification/revalidation programs.
• Project management of process system upgrades and modifications.
• Perform all duties in accordance with GMP requirements, SOPs and controlled documents.
• Will be flexible to take on additional tasks and responsibilities at the discretion of the Associate Director of Validation and Calibration.
• Will act as a role model for the Engineering function and also the wider organization.

What skills you will need:

In order to excel in this role, you will more than likely have:

• A postgraduate qualification in an engineering or science discipline would be advantageous.
• A minimum of 3 - 5 years’ experience working in a pharmaceutical or similar GMP environment as part of a computer systems validation, validation, engineering or IT/OT function.
• Knowledge and experience with facility start-up projects (brown field or green field).
• Experienced in the execution of commissioning and qualification/validation of computerized systems and process equipment (e.g. bioreactors and process vessels, chromatography, ultrafiltration, autoclaves, parts washers).
• Experience in troubleshooting and providing technical and engineering solutions for GMP manufacturing operations and equipment in a biologics processing environment.
• Experience operating in a fully automated Delta V facility.
• Experience of equipment vendor package ownership and system design coordination.
• Understanding of the wider HSE environment, including how to partner with them effectively.
• Ability to lead /direct cross function teams and strong project management skills.
• Flexible approach to work and a positive attitude will be a good fit within the team dynamic.
• Engage cross functionally in conjunction with a site-based team.
• Autonomous and a self-starter who will use their initiative to drive actions forward.
• Demonstrate strong ethics in adhering to company procedures and policies, regulatory standards, and our clients’ expectations.
• Drive a Continuous Improvement Culture within the Engineering team.

We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.

Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.

We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.

Please feel free to speak to us about what flexibility means to you during your application.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, please apply today.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

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