Roche
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.
The Position
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. The Opportunity
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 Who You Are
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 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 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. 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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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. The Opportunity
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 Who You Are
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 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 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. 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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