English
French
Spanish
Project Validation Specialist
Anasco, PR, US
Scientific
Bachelors Degree
Full Time, Temporary
Experienced (Non-Manager)
On-site
Biotechnology/Pharmaceuticals
First Shift (Day)
Anasco, PR, US
Experienced (Non-Manager)
Full Time, Temporary
Biotechnology/Pharmaceuticals
On-site
Scientific
Bachelors Degree
First Shift (Day)
Job details
At Kelly® Science & Engineering we’re passionate about helping you find a job that works for you. How about this one?
We’re seeking Project Validation Specialist to work with one of out top pharmaceutical/biotechnology industry clients at Añasco, PR. With us, it’s all about finding the job that’s just right.
Requirements:
- Bachelor’s Degree in Engineering, Microbiology or similar discipline.
- Minimum of 5-7 years of experience in the medical device and/or pharmaceutical manufacturing environment with effective experience and knowledge in sterilization processes..
- Hands-on experience with EU MDR or MDD remediation projects, compliance projects and process validation required.
- Experience interpreting and applying standards and regulations to medical device microbiological and sterility assurance control programs for the purposes of interpreting data, tactical planning on a daily basis, implementing procedures, and remediation projects.
- Experience in Ethylene oxide sterilization validation and requalification; Bacterial endotoxin test method validation and monitoring; Bioburden test method validation and monitoring; Reusable Medical Devices; Radiation sterilization validation and dose audit management; Controlled environment monitoring
- Knowledge of FDA, OSHA, EPA, and GMP’s and ISO requirements.
- Able to develop technical documentation such as: Change Controls, Validation Plans, Validation Protocols, Technical / investigation reports, SOP, and others.
- Excellent written and verbal communication skills and a strong track record of working cross-functionally. Bilingual ( Spanish and English)
The Project Validation Specialist will be responsible for provide support to Corporate / Division Sterilization Workstream to ensure efficient and timely completion of project deliverables related to sterilization area including, but not limited to new Ethylene oxide sterilization cycle validation, existing Ethylene oxide sterilization cycle re-validation, and sterilization cycle improvements
Once you apply, you’ll proceed to next steps if your skills and experience look like a good fit. But don’t worry—even if this position doesn’t work out, you’re still in our network. That means all our recruiters will have access to your profile, expanding your opportunities even more. Helping you discover what’s next in your career is what we’re all about, so let’s get to work.
Kelly® Science & Engineering PR Offers!
- Exposure to a variety of career opportunities as a result of our expansive network of client companies
- Career guides, information and tools to help you successfully position yourself throughout every stage of your career
- Access to more than 3,000 online training courses through our Kelly® Learning Center
- Weekly pay by W-2
- Vacations, Sick & Holidays paid*
- Christmas bonus*
- *Must comply with minimum established requirements to qualify.
- *Must comply with minimum established requirements to qualify.
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