Principal Validation Specialist
Roche Holdings Inc.
Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding peoples varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.
The PositionPrincipal Validation Specialist
We advance science so that we all have more time with the people we love.
The Opportunity
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You perform equipment Installation, Operational, and Performance Qualifications on a variety of facility and manufacturing equipment in a full Biotech upstream/downstream manufacturing plant.
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Participating/leadingprojects for equipment qualifications, assuming responsibility for timely completion of projects or assigned work, ensuring activities are consistent with project critical path and responding appropriately to changing priorities.
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Training personnel executing equipment qualification with a clear focus on specific activities pertaining to protocol requirements.
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You demonstrate excellent interpersonal skills required to interact with stakeholders such as system owners, quality assurance, and auditors, to regularly communicateproject status internally and externally.
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Youwrite studies, protocols, reports, deviations, and non-conformances in a clear, structured manner directed to reviewers in an FDA regulated environment.
Who You Are
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Bachelor of Science in Industrial, Chemical, Electrical, or Mechanical Engineering with at least 7 years in Equipment and/or Facility Validation isrequired.
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Masters in Engineering, Science, Business, Pharmaceutical Engineering, or Technical Management with at least 5 years in Equipment and/or Facility Validation ispreferred.
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Bachelor of Science in Biology, Chemistry, Microbiology, or Molecular Biologywill be considered with equivalent qualification experience(7 years in Equipment and/or Facility Validation).
Knowledge, Skills, and Abilities
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Equipment/Facility Validation experience in a Medical Device, Diagnostics, Biotech or Pharmaceutical Plant preferred. This includes experience in a cGMP environment.
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Candidate must be proficient in Microsoft WORD, EXCEL, and POWERPOINT. Proficiency in Minitab statistical software and Trackwise is preferred.
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ASQC Certified Quality Engineer is preferred.
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ISPE Certified Pharmaceutical Industry Professional (CPIP) is preferred.
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Computerized Systems Validation experience preferred.
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Equivalent experience in RMS Branchburg will be considered.
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Excellent verbal communication skills required.
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Excellent technical writing skills required.
Relocation benefits are not available for this position.
The expected salary range for this position based on the primary location of New Jersey is 89800,00 – 166800,00 USD Annual. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
Benefits
Who we are
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, weve become one of the worlds leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individuals race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
Roche is an Equal Opportunity Employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.
- Date Posted: November 6, 2024
- Location: Branchburg, NJ
