Sobre este puesto de Quality & Validation Specialist en H.B. Fuller
As the largest pureplay adhesives company in the world, H.B. Fuller’s (NYSE: FUL) innovative, functional coatings, adhesives and sealants enhance the quality, safety and performance of products people use every day. Founded in 1887, with 2024 revenue of $3.6 billion, our mission to Connect What Matters is brought to life by more than 7,500 global team members who collaborate with customers across more than 30 market segments in over 140 countries to develop highly specified solutions that enable customers to bring world-changing innovations to their end markets. Learn more at www.hbfuller.com.
Position Overview
The Quality & Validation Chemist Specialist supports validation, quality, and laboratory activities within a regulated medical device or pharmaceutical manufacturing environment. This role ensures processes, equipment, analytical methods, and quality systems remain compliant with GMP, ISO, and regulatory requirements while providing technical expertise in chemistry and analytical testing.
Primary Responsibilities
Execute and document process, cleaning, analytical method, and equipment validation activities.
Support equipment and system qualification (IQ/OQ/PQ).
Prepare and review validation protocols, reports, risk assessments, and supporting documentation.
Investigate deviations, non-conformances, and out-of-specification (OOS) results.
Perform root cause analysis and support CAPA development and effectiveness reviews.
Review batch records, validation data, and quality documentation for compliance.
Interpret analytical data from techniques such as HPLC, GC, UV, and FTIR.
Support internal, supplier, and regulatory audits and inspections.
Maintain compliance with GMP, ISO, FDA, EMA, and data integrity requirements.
Collaborate with Quality, Laboratory, and Operations teams to drive continuous improvement.
Minimum Requirements
Bachelor's degree in Chemistry or a related scientific discipline.
2–5 years of experience in a pharmaceutical, medical device, or regulated manufacturing environment.
Hands-on experience with validation activities, including process, cleaning, analytical, or equipment validation.
Knowledge of GMP, ISO 13485, FDA, or EU regulatory requirements.
Strong technical writing, documentation, and problem-solving skills.
Preferred Requirements
Postgraduate qualification or certification in Quality, Validation, or a related field.
Experience supporting FDA, or Notified Body inspections.
Knowledge of quality risk management tools, including FMEA, Fishbone, or 5 Whys.
Experience with electronic Quality Management Systems (eQMS).
Familiarity with automation testing, scripting, or GAMP5 frameworks.
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H.B. Fuller is an Equal Employment Opportunity employer and proud to have created a collaborative culture where employees around the world are seen, heard, and respected. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, disability, or marital status or status as a protected veteran, or any other legally protected classification.
H.B. Fuller does not accept unsolicited resumes from recruiters, employment agencies, or staffing firms. To conduct business with H.B. Fuller, a written service agreement must be executed by Human Resources prior to submitting any information relating to a potential candidate. Without a signed service agreement, H.B. Fuller shall not be obligated for payment of any fee or compensation.
