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It's more than a job

As a Contract Logistics Specialist at Kuehne+Nagel, you will manage end-to-end warehousing operations for our customers. By doing so with precision, you not only contribute to the success of your team, but also to the day-to-day operations and success in the warehouse and distribution centres. For example, storing and delivering delicate flowers and fresh ingredients to local stores for everyday lunches and family celebrations. At Kuehne+Nagel, our work truly contributes to more than we imagine.

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The National Quality Specialist - Quality Engineer will be responsible for ensuring that pharmaceutical product storage areas, environmental controls, warehouse equipment, material handling equipment, and related computerized systems are properly qualified and validated in compliance with cGMP and regulatory requirements. This role will oversee the planning, execution, and documentation of qualification and validation activities (master plans, IQ/OQ/PQ, computerized system validation, risk assessments), support audits and inspections, and maintain audit-ready records. Working closely with Quality, Operations, and Engineering teams, the specialist will ensure that facilities, systems, and processes consistently meet regulatory standards and safeguard product quality throughout storage and distribution.The right candidate will have a continuous improvement mindset and a tendency towards 5S in the workplace.

How you create impact

Qualification of Facilities & Equipment

+ Plan, execute, and document IQ/OQ/PQ protocols for warehouses, temperature-controlled storage, HVAC, generators, cold rooms, and monitoring systems.

+ Maintain the validation master plan (VMP) for warehouse operations.

+ Ensure requalification and calibration schedules are met.

Computerized System Validation (CSV)

+ Support validation of GxP systems (e.g., WMS, temperature monitoring, automated equipment).

+ Prepare or review validation deliverables (URS, risk assessments, validation plans, test scripts, summary reports).

+ Ensure compliance with 21 CFR Part 11, EU Annex 11.

Compliance & Documentation

+ Maintain audit-ready documentation in line with FDA, EMA, WHO, and USP guidance.

+ Support inspections and audits, providing validation evidence when required.

+ Ensure procedures (SOPs, work instructions) related to qualification and validation are up to date.

Risk & Change Control

+ Perform risk assessments (e.g., FMEA) for equipment and systems impacting product quality.

+ Support change control processes by assessing validation impact.

Cross-Functional Support

+ Collaborate with Quality Assurance, Operations, Engineering teams and external vendors.

+ Provide qualification/validation training and guidance to warehouse staff.

What we would like you to bring

Shown on internal and external posting

+ Bachelor’s degree in Engineering, Life Sciences, or related field.

+ 5+ years’ experience in validation, quality assurance, or engineering in the pharma/biotech industry.

+ Strong knowledge of cGMP, GDP, GAMP 5, ICH Q7, WHO Annex 9.

+ Experience with temperature-controlled storage and distribution environments.

+ Knowledge of CSV and data integrity principles.

+ Cold Chain and Temperature Mapping experience

+ Ability to drive (PIT)equipment and place loggers at elevated heights within warehouse racking

+ Remote position with 50% travel anticipated.

Advanced skills in Technical Writing, Protocol and Report generation, Risk Assessments, Change Management and GxP Documentation

What's in it for you

There has never been a better time to work in logistics. Bring your skills to an industry that offers you a passion for a job well done and professional career growth. We offer a great compensation and medical/dental benefits package, employee discounts, tuition reimbursement, excellent training programs, and a fun, and interesting global work environment. Kuehne+Nagel is committed to Equal Employment Opportunity (“EEO”) and to compliance with all federal, state, and local laws that prohibit workplace discrimination and unlawful retaliation. Kuehne+Nagel strictly prohibits all discrimination on the basis of race, ancestry, color, age, national origin, ethnicity, religious creed or belief, physical or mental disability, marital or familial status, legally protected medical condition, genetic information, military or veteran status, sex (including pregnancy, childbirth, breastfeeding, or related medical condition), gender (including gender identity and gender expression), sexual orientation, citizenship status, protected activity (such as opposition to or reporting of prohibited discrimination or harassment. Kuehne+Nagel will also make reasonable accommodations for disabled applicants and employees, including accommodations for pregnancy and childbirth, and for the sincerely held religious beliefs of applicants and employees depending upon individual circumstances unless such accommodation would create an undue hardship on Kuehne+Nagel. #LI-remote

Who we are

Logistics shapes everyday life - from the goods we consume to the healthcare we rely on. At Kuehne+Nagel, your work goes beyond logistics; it enables both ordinary and special moments in the lives of people around the world.

As a global leader with a strong heritage and a vision to move the world forward, we offer a safe, stable environment where your career can make a real difference. Whether we help deliver life-saving medicines, develop sustainable transportation solutions or support our local communities, your career will contribute to more than you can imagine.

Kuehne + Nagel is an equal employment/affirmative action employer. If you require an accommodation for any part of the online application process due to a disability, please contact the Employee Services HR Help Desk at 1-800-267-1326 during the hours of 8:00am - 5:00pm EST; Monday through Friday or via e-mail at: [email protected] with the nature of your request. We will answer your inquiry within 24 hours.