Validation Technician
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Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Your Role
Validation Technicians are recognized as a quality presence and technical resource. The Technicians is responsible for the periodic review program, assisting validation engineers with the execution and review of validation documents and ensuring that the qualifications are consistent with quality standard. They will also be interacting cross-functionally with Manufacturing, Project Management, Process & Analytical Development, Quality Control, Quality Assurance, Packaging, Materials Management, Engineering, and Maintenance. Specific responsibilities include:
- Utilize GDP in a GMP atmosphere while executing protocols and reviewing documents.
- Assist with the management and execution the periodic requalification program.
- Conduct annual temperature mapping qualifications on controlled temperature units.
- Execute periodic requalification packages and technical reports while adhering to GDP standards.
- Responsible of maintaining the Validation Documents room.
- Ensure that all validation protocols are stored and maintained electronically in internal quality management systems.
- Retroactively ensuring that historical documents are maintained physically and electronically.
- Assist with the maintenance of a Validation document database (SQL database).
- Conduct the execution of protocols for equipment, analytical instrumentation, cleaning, process controls, and facility qualifications. (including but not limited to FAT/SAT/IOQ and PQ documents).
Who You Are
Minimum Qualifications:
- High School Diploma or GED.
- 1+ years of technical writing experience.
Preferred Qualifications:
- Bachelor’s Degree in Electrical Engineering, Chemical Engineering, or other Engineering discipline OR Biology, Chemistry, or other Life Science discipline.
- 1+ years’ of experience in a GDP setting (e.g. chemical laboratory, pharmaceutical manufacturing, engineering, etc.).
- Knowledge of GMP and knowledge to utilize GDP during document execution and review.
- Proficiency with Microsoft Office products and ability to learn and operate new computer applications.
- Detailed oriented.
RSREMD
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
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Technical Writer, Project Manager, QA, QC, Pharmaceutical, Technology, Quality, Science