Cleaning Validation Engineer
2 weeks ago
**Who are we?**:
**Amaris Consulting** is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade - this is made possible by an international team of 7500 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.
**Brief Call**: Our process typically begins with a brief virtual/phone conversation to get to know you The objective? Learn about you, understand your motivations, and make sure we have the right job for you
**Interviews** (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities
**Case study**: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.
We look forward to meeting you
**Job description**:
About the job
- Drafting of development and validation protocols related cleaning of manufacturing equipment.
- Working with Manufacturing to optimize and validate cleaning processes.
- Contributing to resolution of aberrant cleaning results.
- Compiling data and generating validation reports.
- Basic understanding of cleaning validation concepts including dirty and clean hold times, campaign lengths, and carryover acceptance criteria.
- Supports the periodic review of cleaning validation studies.
- Performs successful and on time resolution of incidents and deviations related to cleaning validation exercises.
- Issues Change Controls required for the implementation of cleaning procedure changes, as needed.
- Ability to train on and assist with equipment cleaning with Manufacturing support.
About you
- Bachelor’s degree in science related field
- Minimum of 2 years’ experience in pharmaceutical / biopharmaceutical companies
- Experience in cleaning validation preferred.
- Proficient in cGMP's and FDA Regulations as it applies to pharmaceutical industry.
- Strong communication skills and self-motivated.
Equal opportunity
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