Pfizer
Pharmaceutical
ValidationSpecialist-EquipmentQualification(f/m)
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Validation Specialist - Equipment Qualification (f/m) at Pfizer. Skills: Equipment Qualification, Validation, Documentation. Qualification and Validation of Facility, Systems and Equipment. Coordination and implementation of qualification activities”
What You'll Achieve.
manage validation deliverables within the expected time; compliance to Pfizer Standards; compliance with GMP; data integrity principles
Industry & Context.
Analytical and quantitative problem-solving skills; Ability to work creatively in a problem-solving environment; problems of diverse scope
Organized transport to and from the site
What They're Looking For.
Must Have
University degree required in Technical Sci (Electrical /Mechanical Eng. ) or Life Science, Analytical and quantitative problem-solving skills, Ability to work creatively in a problem-solving environment, Competency in MS Office applications, Basic knowledge of statistics, Fluent Croatian and proficiency in English
Nice to Have
Previous working experience in validation / qualification in pharmaceutical industry is preferred, Working knowledge of equipment qualification specifically for pharmaceutical industry is preferred
What You'll Do.
Qualification and Validation of Facility
Systems and Equipment
Coordination and implementation of qualification activities
Planning and execution of qualifications
Coordination of qualification activities with external contractor
Preparation and authoring of qualification documentation
SAT and testing witness
Documentation for Facility/Utilities/Systems/Equipment Qualification
Review of documentation and records
Preparation of periodic review reports
Assessment of changes related to qualification
creation and execution of qualification documentation deliverables
Ensure Facility / Utilities/ Systems/ Equipment Qualification and Validation document deliverables are following site and corporate policies
Maintain Equipment Qualification in Change Management Process
Investigate validation discrepancies
Develop approaches and risk mitigation strategies
How You'll Work.
Team & Collaboration
Work closely with business stakeholders; Work closely with technical support groups; Tendency for teamwork
Communication Scope
written communication skills; verbal communication skills
Full Job Description
**Work location:** Savski Marof As a Equipment Qualification Associate you will be responsible for Qualification and Validation of the Facility, Systems and Equipment. Your duties as the Equipment Qualification Associate will be varied, however the key duties and responsibilities are as follows: * Facility / Utilities/ Systems qualification and Equipment Qualification in the manufacturing (Biological Drug substance and Aseptic Sterile drug product), warehousing and other manufacturing related areas: * Coordination and implementation of qualification activities related to facility / systems and equipment. * Planning and execution of qualifications (IQ/ OQ/PQ), requalification, periodic qualifications and periodic reviews * Coordination of qualification activities with the external contractor, participation in the testing (FAT, SAT, IQ/OQ/PQ) and supervision of qualification activities * Preparation and authoring of qualification / validation related documentation in Pfizer e-documentation system * Participation in FAT, SAT and testing witness in the QC Laboratory HPLC, UPLC systems and other lab equipment to ensure that existing and new equipment are fully qualified * Documentation for Facility/Utilities/ Systems/ Equipment Qualification * Preparation and authoring of all qualification related documentation (write and execute URS, DQ, SRA, IQ, OQ, PQ validation summary reports) * Review of documentation and records of the tests performed * Preparation of periodic review reports * Assessment of changes related to the qualification of Facility/Utility/ Systems/ Equipment. Deliverables include but not limited to: development of a validation plan; utilization of SOPs; documented training on SOPs; development of detailed specifications (URS); development of protocols/ test plan and/or test scripts and reports as well as other validation/qualification related documentation. Your success will be evaluated based on your ability to manage validation deliverables within the ex
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