Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
At Grifols, we believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities that foster an inclusive environment.
POSITION SUMMARY:
The Validation Engineer will write, review and execute Validation Plans ,Protocols and Reports for Secondary Packaging Projects and Revalidations ensuring compliance to all relevant global and local quality and validation procedures /standard.
Initial requirements to focus on the areas of Packaging Equipment Qualification and Temperature Mapping with Utilities, Cleaning Revalidation to follow.
Represent Validation at technical forum include external and internal audits.
What you will be doing?:
* Write, review and execute Validation Protocols and Reports (for Equipment, Utilities, Processes, Cleaning, Temperature Mapping and Equipment Software) ensuring compliance to all relevant global and local quality and validation procedures/standards
* Represent Validation at both internal and external audits by regulatory agencies, including HPRA and FDA.
* Generation and review of project documentation (User Requirement Specifications, validation protocols, reports etc.) and Standard Operating Procedures.
* Supporting validation activities including review of documentation and hands-on execution of validation activities (FAT, SAT, IQ, OQ, PQ etc) to ensure equipment meets current GMP requirements and industry standards.
* Demonstrates technical knowledge and ability to adapt to changing circumstances. Works with other departments Operations, Quality, and Maintenance ) to execute qualification and validation efforts in support of site projects.
* Completion of risk assessments, closure of corrective and preventive actions (CAPA’s)
* Investigates and troubleshoots problems and determines solutions or recommendations for changes and/or improvements.
* Performs other validation associated activities as defined by Manager or Director.
KEY COMPETENCIES
Packaging Equipment Qualification
Temperature Mapping
Computer System Validation
Clean Utilities
Cleaning Validation, preferable
Commissioning and Qualification
Documentation (Writing SOPs, Protocols, Reports)
Auditing
Strong communication / presentation skills during internal/external audits.
PERSON SPECIFICATION:
* Project Management Experience
* Hands-on knowledge of execution of Validation
* Experience in a Quality or Validation Role within Pharma sector
* Experience with Software validation for manufacturing
* Excellent Technical Writing and analytical skills.
* Familiarity with cGMPs and industry and federal guidelines required.
* Experience with Word, Excel and Access computer applications.
* Strong interpersonal skills for interactions with other departments.
* Degree in Science/Engineering and/or Min 4 years Validation experience
* Experience in representing client companies during internal (Corporate) audits and external (FDA and HPRA) audits
* Working knowledge of HTM 01 (Part C, Steam Sterilization) Autoclaves
* Familiarity with ISO-14644 (Cleanrooms and Associated Environments)
* Familiarity with Annex 1 (Manufacture of Sterile Medicinal Products)
* Experience within aseptic manufacturing environment
Our Benefits Include:
* Highly competitive salary
* Group pension scheme - Contribution rates are (1.5% / 3%/ 5%/ 7%) and company will match
* Private Medical Insurance for the employee
* Ongoing opportunities for career development in a rapidly expanding work environment
* Succession planning and internal promotions
* Education allowance
* Wellness activities - Social activities eg. Padel, Summer Events
We understand that self-doubt can hold talented individuals back from applying for opportunities. We encourage everyone who meets the qualifications to apply – we're excited to hear from you
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Grange Castle International Business Park, Grange, Co. Dublin, D22 K2R3 (https://www.google.com/maps/place//data=!4m2!3m1!1s0x486773bd46855f9f:0xbe0e9ad7159de122?sa=X&ved=1t:8290&ictx=111)
Learn more about Grifols
Req ID: 530960
Type: Regular Full-Time
Job Category:
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