Validation Engineer
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Job Location:
Arlington Heights, WA - USA
Yearly Salary:
$ 66000 - 99000
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Job Description Summary
Validation Engineer This role will be responsible for ensuring compliance with global regulatory and industry standards for the storage handling and transportation of pharmaceutical products. This role focuses on maintaining validated systems and processes for distribution including transportation studies packaging qualifications and controlled shipping procedures. The engineer will develop and maintain SOPs execute risk assessments and ensure adherence to Good Distribution Practices (GDP) to safeguard product quality throughout the supply chain.Our Pharmaceutical Diagnostics (PDx) business is the number one global supplier of contrast media and molecular imaging agents used to enhance medical imaging exams. Used throughout all major disease area diagnostic and treatment pathways PDx products support three patients every second around the world.
Job Description
Roles and Responsibilities
Lead and maintain validation programs for product storage and transportation systems including thermal mapping lane qualification and packaging validation.
Develop review and update SOPs governing controlled shipping and storage practices.
Ensure compliance withWHO TRS 961 Annex 9USP <1079> Good Storage and Distribution PracticesEU GDP Guidelines andPDA Technical Report 64.
Conduct risk assessments (e.g. FMEA HACCP) for transportation and storage processes to mitigate temperature excursion risks.
Manage and maintain documentation for transportation studies packaging qualifications and deviation investigations related to shipping/storage.
Collaborate with cross-functional teams including Quality Assurance Logistics and external suppliers to ensure robust distribution processes.
Support audits and inspections by providing evidence of compliance for storage and distribution systems.
Provide technical expertise for change control CAPA and deviation management related to storage and distribution.
Required Qualifications
Bachelors degree in Engineering from an accredited university or college (or a high school diploma / GED with at least 6 years of experience in technical roles in the pharmaceutical industry).
Desired Characteristics
Strong oral and written communication skills. Ability to document plan and execute programs.
1 years of experience in validation quality or engineering roles within pharmaceutical or biotech industries.
Knowledge of temperature-controlled packaging systems data loggers and thermal qualification software.
Familiarity with global GDP requirements and transportation management.
Experience with ISPE GPG Cold Chain Management WHO Annex 9 USP <1079> EU GDP and PDA TR 64.
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus and drive ownership always with unyielding integrity.
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything youd expect from an organization with global strength and scale and youll be surrounded by career opportunities in a culture that fosters care collaboration and support.
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We will not sponsor individuals for employment visas now or in the future for this job opening. For U.S. based positions only the pay range for this position is $66000.00-$99000.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills qualifications experience and addition this position may also be eligible to earn performance based incentive compensation which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package including not but limited to medical dental vision paid time off a 401(k) plan with employee and company contribution opportunities life disability and accident insurance and tuition reimbursement.Additional Information
GE HealthCare offers a great work environment professional development challenging careers and competitive compensation. GE HealthCare is anEqual Opportunity Employer. Employment decisions are made without regard to race color religion national or ethnic origin sex sexual orientation gender identity or expression age disability protected veteran status or other characteristics protected by law.
GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19 some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.
Relocation Assistance Provided: No
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
About Company
GE HealthCare provides digital infrastructure, data analytics & decision support tools helps in diagnosis, treatment and monitoring of patients
