Validation Specialist

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.

The Validation Specialist ensures the qualification/validation activities for existing and new equipment, facilities, utilities, and processes are conducted in accordance with corporate and regulatory requirements. This Specialist develops 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. Executes Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) protocols with input/oversight from manager & senior level validation representatives. This Specialist assists with implementing improvements around current qualification/validation processes with guidance from manager & senior level validation representatives.

The opportunity:

• Prepares and executes 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 protocol strategy, authoring protocols, execution, and final report writing.

• Practice and partner with Operations to ensure compliance to cGDP, cGMP, FDA and ISO13485 guidelines.Supports the qualification and validation activities to maintain compliance. Partners with Business/Equipment Owners/Stakeholders, equipment vendors, and Quality on completion of validation deliverables.

• Perform prequalification engineering studies to characterize equipment performance.Apply program / project management tools to define and monitor project timelines, ensuring timely achievement of overall project goals and establishing priorities that are in line with the overall business needs.

• Effectively communicate qualification and validation timelines, risks and support needed to align all functions to achieve desired project goals.

• Makes suggestions to improve work processes within the Validation Team.Consistently uses company concepts, policies and procedures, familiar with and follows standard practices.Documents 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

• 1-4 Years of related experience

• Experience in a Regulated Industry preferably FDA and knowledge of Design Control Guidelines is preferred

Knowledge, Skills and Abilities

• Equipment/Facility Validation experience in a Medical Device, Diagnostics, Biotech or Pharmaceutical Plant desired. This includes experience in a cGMP environment.

• Demonstrates potential for technical proficiency, engineering creativity, and collaboration with others and independent thought.

• Understanding in the manufacture of assays, reagents and instruments as well as qualification and validation principles, practices and tools used in that transfer.

• Strong communication and technical writing skills for protocol and report generation.

• The candidate must be a self-starter with the ability to work with minimal supervision in a fast paced environment. The candidate must have the ability to prioritize and manage multiple projects and priorities. The candidate must be a team player, willing to help others and cross train them as necessary.

• Candidate must be familiar with Google Platform (i.e. Sheets,Docs) Microsoft (i.e. Word, Excel, and Powerpoint). Proficiency in Minitab statistical software and SAP is a plus.

• Knowledge of continuous improvement / lean / Six sigma manufacturing principles is a plus.

• ASQC Certified Quality Engineer is a plus