Pfizer

Validation Specialist - Equipment Qualification (m/f)

Posted Yesterday

Be an Early Applicant

Zagreb, HRV

Hybrid

Junior

Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical

We’re in relentless pursuit of breakthroughs that change patients’ lives.

The Role

The role involves qualification and validation of facilities, systems, and equipment in the pharmaceutical industry, including documentation and compliance with GMP standards.

Summary Generated by Built In

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 expected time and compliance to Pfizer Standards, EU GMP, 21 CFR part 211, EU GMP Annex 15 and other relevant regulatory requirements.
Duties and Responsibilities

Planning, creation and execution of qualification documentation deliverables (IQ/OQ/PQ plans, protocols, tests, reports, etc.) including participation in testing aligned with Pfizer Standards, EU GMP, 21 CFR part 211, EU GMP Annex 15 and other relevant GMP requirements.
Ensure Facility / Utilities/ Systems/ Equipment Qualification and Validation document deliverables are following site and corporate policies and procedures following Risk-based Lifecycle Approach from URS (User Requirement Specifications) development through system retirement.
Maintain Equipment Qualification in Change Management Process.
Work closely with business stakeholders and technical support groups to thoroughly investigate validation discrepancies and drive best-practice for validation.
Self-motivated / self-starter person will work independently under Validation department, with ability to work on problems of diverse scope where a solution is not readily apparent.
Strong commitment to continually improve compliance with GMP and data integrity principles.
Proactively develop approaches and risk mitigation strategies.

Qualifications

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
Previous working experience in validation / qualification in pharmaceutical industry is preferred

Skills/Competencies

Technical proficiency, attention to detail, creativity, innovation, and independent thought.
Working knowledge of GMP, FDA and EU regulations including 21 CFR Part 11
Working knowledge of equipment qualification specifically for pharmaceutical industry is preferred
Strong communication skills - Demonstrates strong written and verbal communication skills.
Tendency for teamwork
Adaptable, systematic and punctuate

What we offer:

Organized transport to and from the site
Work with modern automated systems
Opportunity for working on projects with other Pfizer sites and locations
Strong education program
Christmas, Easter and holiday bonus
Affordable meals in an on-site cafeteria
Opportunities for career enhancement and development
Yearly pay increase and bonus based on performance
Further professional development in a supportive environment
Free health check-ups
Free psychotherapy and coaching sessions for employees and people close to them
Bravo employee recognition system
Free fruit and hot beverages on the site
Insurance from accident 24/7

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Quality Assurance and Control

Skills Required

University degree in Technical Science or Life Science
Previous working experience in validation/qualification in pharmaceutical industry
Fluent Croatian and proficiency in English
Competency in MS Office applications
Basic knowledge of statistics

What the Team is Saying

Pfizer Compensation & Benefits Highlights

Parental & Family Support — U.S. materials describe up to 26 weeks of parental leave (including up to 12 paid non‑medical weeks), with phased return‑to‑work plus fertility, adoption, and surrogacy financial support, backup care, lactation support, and caregiver leave. These offerings indicate depth in family‑building benefits and day‑to‑day caregiver resources.
Healthcare Strength — Core programs commonly include medical, prescription drug, dental, vision, mental‑health/EAP resources, disability insurance, preventive health programs, and free or reduced‑cost vaccinations. Voluntary Benefit Extras and wellness resources broaden coverage and access.
Retirement Support — Career pages and postings note a 401(k) with company matching plus an additional company retirement savings contribution in some plans. Company materials also reference financial‑planning education and colleague‑directed retirement funds.

Learn more about Pfizer's Compensation & Benefits →

Pfizer Insights

What's It Like to Work at Pfizer? Pfizer Culture & Values Pfizer Career Growth & Development What's the Work-Life Balance Like at Pfizer? Pfizer Leadership & Management Pfizer Company Growth, Stability & Outlook

View all jobs at Pfizer

View Pfizer Profile

Report Job

Am I A Good Fit?

beta

Get Personalized Job Insights.

Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.

The Company

HQ: New York, NY

121,990 Employees

Year Founded: 1848

What We Do

Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.

Why Work With Us

We are the inventors, the problem solvers, the big thinkers — those who surmount any hurdle to deliver breakthrough medicines to the people who are counting on them the most.