Global CSV Senior Manager OT
Does it sound interesting to be a Global CSV Senior Manager OT in a newly created position? Does an international working environment where the key priority is to be data driven sound challenging? Do you want to make a difference in the fields of reproductive medicine and maternal health, and in specialty areas within gastroenterology and urology?
As a Global CSV Senior Manager OT, you are responsible to deliver an efficient global and compliant validation strategy for multi-site, as well as for local projects/programs implementation of OT solutions. You should ensure that the validation strategy, roles & responsibilities between global/ local functions and personnel are clear and understood to ensure compliance of all OT GMP systems and answer accurately to any questions from health authorities. It means also to maintain the validated status of OT solutions across all manufacturing sites.
Your new team
You will be joining a newly created team of five people, with a desire to expand by 2 team members. We are all working in the OT area, and you are going to refer to the Head of OT, based in Switzerland. You are working in close collaboration with our departments from Germany, Israel, Portugal, and Switzerland, among others.
Your new workplace is at the Ferring International Pharma-Science Center (IPC) in our spectacular and state-of-the-art new domicile, a landmark located next to “Den Blå Planet”, near Copenhagen Airport.
- Maintain the validated status of global OT Systems and Applications with the system owner(s) and the local CSV experts.
- Ensure that CSV related CSOPs are understood and implemented for OT Systems and Applications. Any required changes to the existing validation approach for OT Systems and Applications must be carried out (i.e.: updating existing documentation or adding new documents according to a change in the related CSOPs).
- Accountable to define the validation strategy for new global OT project implementations and upgrades, ensuring easy ongoing maintainability for routine changes or where changes are expected to be more frequent (i.e.: splitting the validation documentation for each interface and for each custom-made user screen).
- Responsible to create the global CSV documents templates to support new OT project implementations according to the validation strategy and provide support to local CSV experts whenever required during global project execution.
- Enforce the use of electronic systems for testing (i.e.: RQM) and ensure similar testing structure among projects.
- Participate in the assessment of system reviews, deviations, CAPA, Changes, continuous improvement and troubleshooting related to Global OT Systems and Applications.
- Establish and lead the process/framework to monitor compliance adherence of OT Systems and Applications both globally and locally with the sites.
Required Experience & Competences:
- Bachelor’s degree or Master’s degree with a preference in Computer Science or related field.
- Senior experience in an operational IT/OT/Automation position with a good understanding of pharma, chemistry, food industry within industrial company.
- 3+ years of experience of CSV projects and computer validation methodologies, including ISPE GAMP 5
- 3+ years of experience in writing, reviewing and executing CSV documentations (CVP/CVR, IQ, OQ, PQ)
- Very good knowledge of PLC, SCADA, Historian, Data Collector implementation
Location: Copenhagen, Denmark (preferably) or Lisbon (an option), Portugal.
What we offer:
- A newly created position with the opportunity to have a strong impact on the role and a strong influence on the entire company’s growth strategy.
- Make a difference in the fields of reproductive medicine and maternal health.
- An international working environment.
- Flexible working policy with the possibility to work from home up to two days a week.
- A lot of benefits including high end kitchen offering daily takeaway and purchase of Friday delicacies.
About Ferring Pharmaceuticals:
Ferring Pharmaceuticals is a leader in reproductive medicine and maternal health, and in specialty areas within gastroenterology and urology. At Ferring International PharmaScience Center (IPC) in Copenhagen we are nearly 600 people, primarily scientist and specialists working to break new land to help people live better lives. We focus on our R&D efforts on peptide-based drugs and biotechnology derived medicined. Read more at www.ferring.com.
Recruitment is handled by iHeadHunt,so feel free to contact Marle Kettunen on email@example.com or mobile: +358 50 336 1636, if you want to know more about the role. Applications and CV are continuously assessed, so please apply as soon as possible.