Validation Engineer/Specialist

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

GenMark Diagnostics in Carlsbad, CA seeks talented validation specialists for our Sustaining Engineering and Maintenance Team. We focus on quality to ensure a patient-focused and compliant foundation. Our culture fosters trust, collaboration, and diversity, empowering all employees to make a significant impact. Join us in our mission to improve healthcare through innovative and reliable diagnostic solutions.

In this role, you are applying your knowledge and experience with IQ, OQ, PQ processes for custom medical devices, including drafting and managing documentation for compliance with GMP and GDP standards. Detail and integrity in preparing documents for auditors is crucial. Collaboration is essential to identify calibrated equipment and perform qualification activities, ensuring streamlined operations and reliable production equipment.

Also, you are:

• Preparing and performing 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.
• Practicing and partnering with Operations to ensure compliance with cGDP, cGMP, FDA, ISO13485 and other guidelines or regulations. Also, you partner with Business/Equipment Owners/Stakeholders, equipment vendors, and Quality on completion of validation results.
• Performing prequalification engineering studies to characterize equipment performance.
• Applying 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 timelines, risks and support needed to align all functions to achieve desired project goals. Makes suggestions to improve work processes.
• Documenting equipment/facility/utility qualification/validation activities accurately and appropriately, and according to established formats and procedures.
• Other duties as assigned by management.

• A Bachelor's degree in an Engineering, Engineering Technology, or Life Science field is required
• This role requires 1 to 4 years of proven experience in a regulated industry. Preferably FDA or GMP-regulated, with knowledge of Design Control Guidelines. An equivalent combination of education and experience may be considered.
• Equipment/Facility Validation in a Medical Device, Diagnostics, Biotech or Pharmaceutical Plant desired.

Behaviors, competencies, and qualities of the ideal applicant.

• Demonstrates potential for independent thought, technical proficiency, engineering creativity, and collaboration with others, as well as
• Understands 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.
• Familiarity with Google Platform (i.e. Sheets,Docs) Microsoft (i.e. Word, Excel, and PowerPoint).
• Proficiency in Minitab statistical software and SAP; knowledge of continuous improvement /lean / Six sigma manufacturing principles is a plus.
• Licenses and Certifications: ASQC Certified Quality Engineer or ISPE Certified Pharmaceutical Industry Professional (CPIP) are plusses

The expected salary range for this position based on the primary location of CA is 56,600 - 88,679 USD Annually. 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

GenMark is now a proud member of the Roche Group, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. As a global leader in healthcare, Roche Diagnostics offers a broad portfolio of products, tools and services that help in the prevention, diagnosis and management of diseases like HPV, HIV, hepatitis and diabetes as well as other medical conditions, such as fertility and blood coagulation. With the addition of GenMark to the Roche Group, syndromic infectious disease diagnostics is now added to the long list of disease states and conditions that the Roche Group addresses. GenMark's ePlex true sample-to-answer system offers unique solutions to address the most significant challenges facing clinical laboratories, while supporting hospital systems to deliver patient-centered, value-based care. ePlex streamlines the diagnostic workflow from physician order entry to the final test report and is the true sample-to-answer solution designed to improve patient care, reduce costs, and increase lab efficiency. GenMark is headquartered in Carlsbad, California.

GenMark is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

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.