Validation Specialist

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The Position

Our work creates a future where we all have more time with the people we love. We are Roche.

The team, Equipment and Facility Validation (EFV) is part of the Technical Laboratories Controls (TLC) department. EFV focuses on the qualification of GxP equipment, utilities, and facilities used to produce in-vitro diagnostics reagents and components, our main business in the Roche Branchburg biotech upstream/downstream manufacturing plant. We ensure Roche’s right to operate by complying with all regulatory requirements.

Your Opportunity

As a Validation Specialist, you develop qualification/validation documentation associated with the equipment or system lifecycle ensuring the requirements facilitate robust qualification and validation activities that will conform to the user needs and intended purpose. You are contributing improvements to current qualification/validation processes with senior-level guidance.
Also, you are:

• Preparing and executing Installation/Operational/Performance Qualifications (IQ/OQ/PQ) protocols on facilities, manufacturing process equipment, and analytical testing equipment. Qualification includes conception of qualification assessments, basic protocol strategy, authoring protocols, execution, and final report writing.
• Supporting the qualification and validation activities to ensure compliance with cGDP, cGMP, FDA, and ISO13485 guidelines. You are actively partnering with Operations, to ensure everything is compliant.
• Partnering actively with Business/Equipment Owners/Stakeholders, equipment vendors, and Quality. Use of company concepts, policies, and procedures.
• Performing prequalification engineering studies to characterize equipment performance.
• Applying program/project management tools to define and monitor project timelines, establishing priorities that align with the business needs. Communicating effectively timelines, risks, and support needed.
• Documenting equipment/facility/utility qualification/validation activities accurately and appropriately, and according to established formats and procedures.

Who you are

• You hold a Bachelor's Degree in an Engineering/Engineering Technology or Life Science discipline and bring 1-4 Years of related experience.
• Preferred: 1 year experience in a Regulated Industry preferably FDA; knowledge of Design Control Guidelines.
• An equivalent combination of education and/or experience is accepted.

Behaviors, competencies, and qualities of the ideal Validation Specialist

• Experienced in a Medical Device, Diagnostics, Biotech or Pharmaceutical Plant with Equipment/Facility Validation, including experience in a cGMP environment.
• Assertive communication and technical writing skills for protocol and report generation.
• Brings potential for technical proficiency, and engineering creativity.
• Collaboration with others; cross-train others as necessary. Ability to contribute to project teams.
• Understanding of the manufacture of assays, reagents, and instruments.
• Good prioritization management based on the needs of the manufacturing area with guidance from the reporting manager.
• Familiarity with Google and Microsoft suites. Proficiency in Minitab statistical software and SAP is a plus.
• Knowledge of continuous improvement / Lean / Six Sigma manufacturing principles is a plus.

Relocation benefits are not offered for this job 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.

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