Automation CSV Specialist
Automation CSV Specialist
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Salary Not Disclosed
1 Vacancy
Job Description
This is an exciting time to join us and help shape the future. Its an opportunity to be part of something special
Job Purpose:
Reporting to the Nyon Automation & GxP Computerized Systems Lead endorse the role of an SME for Control System. Ensure and demonstrate that the specifications the commissioning the installation the operational and performance qualification of new and modified automation and computerized systems are designed and implemented to produce a product that repeatedly and reproducibly meets critical attributes. Ensure the reliability of the existing automation and computerized systems and follow their maintenance upgrade development and installation.
This role will provide YOU the opportunity to lead key activities to progress YOUR career these responsibilities include some of the following
Project support: as an SME from solution design & implementation to operational support.
Operational support: Implements troubleshoots and maintains Control System automation computerized and vision system to support production and labs with a specific and according to GMP rules.
Change management: as an SME evaluate the potential impact of a change on systems and support the implementation of the change.
EHS: Apply and support Haleon EHS requirements anticipate change consequences on health security and environment.
Technology watch:
- Stay abreast of changing technologies and provides guidance/training to personnel on the impact of those new technologies on regulatory compliance and the impact on potential areas of new or changing responsibilities workflows and business processes.
- Improve and develop method related to the automation standardization Provides expertise for evaluation of new software: perform feasibility and performance studies Training: Provide the first training level to the end user and/or the others Automation & GxP Computerized Systems team members.
CSV:
- Proceed to the validation of the automated and computerized systems according to Haleon rules (logic security backup / restore & archive / retrieve processes change and deviation management maintenance recovery and continuity planning CSV documentation management)
- Manage computerized systems and automated systems validation projects: definition of the validation strategy risk assessment and test protocols (Installation Qualification Operational Qualification and User Acceptance Tests) in accordance with international standards (GAMP5 and Haleon rules to ensure their compliance with regulatory requirements 21 CFR Part 11 EU GMP Annex 11
- Perform the change requests of GxP validated Computerized Systems. Investigate deviations and define appropriate corrective and preventive actions to avoid re occurrence.
GMP:
- Enforce and drive GMP standards
- GMP knowledge experience to support the requirements expected by Swissmedic European union agencies and other regulatory bodies to assure that our products meet all cGMP requirements together with our operations and documentation system
- Ensure local implementation of Haleon Quality Standard
- Maintain and approve local SOP related to the activity
- Ensure Change management related to the activity
- Ready for any Internal or External Audit
Knowledge/Education Required :
- Degree in Automation Engineering and/or IT (Federal Diploma of Higher Education / Bachelor / Engineer degree)
- 3 years in Automation and GxP Systems within Pharmaceutical or other FMCG
- Good knowledge of GxP requirement and GxP Control System Qualification / Validation process
- Mastery on Siemens PLC (S7 and Wonderware software suite.
Care to join us. Find out what life at Haleon is really like www.haleon/careers/
At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives generates curiosity to create unmatched understanding of each other and promotes fair and equitable outcomes for everyone. Were striving to create a climate where we celebrate our diversity in all forms by treating each other with respect listening to different viewpoints supporting our communities and creating a workplace where your authentic self belongs and thrives. We believe in an agile working culture for all our roles. If flexibility is important to you we encourage you to explore with our hiring team what the opportunities are.
As you apply we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured Hiring Managers do not have access to this information and we will treat your information confidentially.
Haleon is an Equal Opportunity Employer. All qualified applicants will receive equal consideration for employment without regard to race color national origin religion sex pregnancy marital status sexual orientation gender identity/expression age disability genetic information military service covered/protected veteran status or any other federal state or local protected class.
Accommodation Requests
If you require a reasonable accommodation or other assistance to apply for a job at Haleon at any stage of the application process please let your recruiter know by providing them with a description of specific accommodations you are requesting. Well provide all reasonable accommodations to support you throughout the recruitment process and treat all information you provide us in confidence.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
