Principal Validation Specialist
3 weeks ago
The Position
Roche in 50 words: A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche.
Job Summary
The Principal Validation Specialist ensures that qualification validation and procedure requirements are met for all existing and new equipment / facilities / utilities, systems and processes by preparing, reviewing, and executing detailed qualification/validation protocols that meet the relevant testing standards in support of the site and the projects / programs.
The Opportunity
- Writes and executes Equipment, Facility, and Utilities Installation/Operational/Performance Qualifications (IQ/OQ/PQ) protocols on a variety of facility and manufacturing process equipment and analytical testing equipment in a full Biotech upstream/downstream manufacturing plant. Qualification includes conception of qualification assessments, (basic to complex) protocol strategy, authoring protocols, execution, and final report writing.
- Leads and provides qualification and validation support to complex and/or multinational projects in your assigned area. Participates and leads project planning, qualification/validation scheduling, process updates, and experimental design. Assumes responsibility for timelines completion of projects or assigned work, ensuring activities are consistent with project critical path and responding appropriately to changing priorities.
- Effectively communicate qualification and validation timelines, risks and support needed to align all functions to achieve desired project goals.
- Ensures validation program meets corporate and regulatory expectations and makes suggestions to improve work processes.
- Prepares and delivers presentations of project results to others; presents data to larger and more diverse audiences.
- Utilizes Continuous improvement/Lean/Six Sigma manufacturing concepts to improve processes.Ensures collaboration with Business/Equipment Owners/Stakeholders, equipment vendors, and Quality on completion of validation deliverables.
- Serves as an expert resource to other departments (e.g., Manufacturing/Operations, Development, Quality, Regulatory Affairs, and Technical Services), provides timely response and follow-ups.
Who You Are
- Bachelor's degree in an Engineering/Engineering Technology or Life Science discipline with a minimum of 6 years relevant industry experience in Equipment and/or Facility Validation or with MS in Engineering: 6 or more years of experience in Complex mechanical/chemical systems development/validation.
- Solid understanding in the manufacture of assays, reagents and instruments as well as Verification and Validation principles, practices and tools used in that transfer.
- Proven ability to work on complex problems with analysis of situations or data towards successful outcomes.
- Demonstrated ability to apply Lean and 6 Sigma methodology in all that you do and a passion to drive It throughout the organization
- Proven ability to contribute and interact productively and collaboratively with project teams.
- Excellent verbal communication skills, interpersonal skills and technical writing skills.
Relocation benefits are not available for this posting
Who we are
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's 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 individual's 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.
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Branchburg, United States Roche Full timeThe Position At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity, and diversity. We believe every employee makes a difference. We are passionate about transforming...
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