{"schemaVersion":"jobsearcher.job.v1","id":"edd0580384b161007dddb2fa","url":"https://jobsearcher.com/jobs/edd0580384b161007dddb2fa","canonicalUrl":"https://jobsearcher.com/jobs/edd0580384b161007dddb2fa","title":"Lead Engineer, Quality Control","description":"Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes.\n\nYour Role:\nThe Lead Engineer, Quality Control shall provide technical validation support for processes, equipment, networks, software that has been newly installed, upgraded, replaced and modified in Quality Control. This role is the primary interface with Quality Control for Validations and Facilities on QC equipment.\n\nKey Responsibilities:\n\nTake on lead role for select Capex and Opex projects within the QC department. This includes planning, project management, proposal, budgeting, and execution.\n\nPlan and procure new QC equipment as required.\n\nPlan and coordinate laboratory movement of QC equipment.\n\nGenerate and review relevant documents for new equipment\n\nSchedule and manage routine PM on QC equipment\n\nAssess equipment needs for QC and manage equipment purchasing process\n\nWrite and manage Engineering Change Request (ECR) documents\n\nAuthor User Requirement Specification (URS) and/or Requirement Specification documents for quality control equipment/systems and processes\n\nGenerate and execute Installation, Operational and Performance/Process qualification (IQ, OQ, PQ) protocols and final reports that comply with corporate and regulatory requirements\n\nCoordinate and oversee validation protocol execution or validation activities\n\nEvaluate and analyze qualification data collected during projects while verifying acceptability of the data and compliance with the approved protocol\n\nEnsure any deviations to protocols and/or deviations to acceptance criteria are adequately addressed, documented and reviewed\n\nImprove validation and equipment processes\n\nAssist department manager in developing realistic time and resource requirements for validation activities in support of company expectations\n\nProvide input and assist in change control assessment and Part 11 assessment for validated systems\n\nReview Standard Operating Procedures (SOPs) and ensure the operational parameters described in the SOP for the equipment reflect validated conditions\n\nAssist department manager on other types of projects/managerial responsibilities as needed\n\nSchedule and manage routine instrument PM processes\n\nOccasional overnight travel by land and/or air may be required to attend seminars or conferences or client meetings\n\nPerform other duties as assigned\n\nMinimum Qualifications:\n\nRequires a BA/BS in Science (such as Biology, Microbiology, Biochemistry, Chemistry) or other technologically related field plus 4-5 years' work experience in a biopharmaceutical/pharmaceutical manufacturing environment of which 3 years were directly involved in validations.\n\nMust have knowledge of validation principles, standard concepts, practices, procedures and requirements in a GMP regulated environment.\n\nAn understanding of Good Automated Manufacturing Practice (GAMP), SDLC, Risk Assessment and 21 CFR Part 11 Electronic Records and Electronic Signatures required.\n\nPosition Type/Expected Hours of Work:\nThis role is a full-time onsite position. Days and hours of work are Monday through Friday unless otherwise stated by Supervisor. The employee must also have the ability to work overtime and/or weekends when necessary.\n\nCompensation:\nWe offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.\n\nThe compensation range for this role is $105,000 - $124,000 annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.\n\nWho you are:\n\nYou have a \"bring it on!\" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.\n\nYour written and verbal skills are out of this world, and you communicate with clarity and confidence.\n\nYou have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.\n\nYou are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.\n\nPhysical Demands & Work Environment:\nIn this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 25 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.\n\n#J-18808-Ljbffr","company":"Avid Bioservices","rawCompany":"avid bioservices","city":"Tustin","state":"CA","isRemote":false,"isActive":false,"createdAt":"2026-08-13T03:33:52.692Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"},{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"}],"industries":[{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"},{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"325414","title":"Biological Product (except Diagnostic) Manufacturing","slug":"biological-product-except-diagnostic-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Lead Engineer, Quality Control","description":"Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes.\n\nYour Role:\nThe Lead Engineer, Quality Control shall provide technical validation support for processes, equipment, networks, software that has been newly installed, upgraded, replaced and modified in Quality Control. This role is the primary interface with Quality Control for Validations and Facilities on QC equipment.\n\nKey Responsibilities:\n\nTake on lead role for select Capex and Opex projects within the QC department. This includes planning, project management, proposal, budgeting, and execution.\n\nPlan and procure new QC equipment as required.\n\nPlan and coordinate laboratory movement of QC equipment.\n\nGenerate and review relevant documents for new equipment\n\nSchedule and manage routine PM on QC equipment\n\nAssess equipment needs for QC and manage equipment purchasing process\n\nWrite and manage Engineering Change Request (ECR) documents\n\nAuthor User Requirement Specification (URS) and/or Requirement Specification documents for quality control equipment/systems and processes\n\nGenerate and execute Installation, Operational and Performance/Process qualification (IQ, OQ, PQ) protocols and final reports that comply with corporate and regulatory requirements\n\nCoordinate and oversee validation protocol execution or validation activities\n\nEvaluate and analyze qualification data collected during projects while verifying acceptability of the data and compliance with the approved protocol\n\nEnsure any deviations to protocols and/or deviations to acceptance criteria are adequately addressed, documented and reviewed\n\nImprove validation and equipment processes\n\nAssist department manager in developing realistic time and resource requirements for validation activities in support of company expectations\n\nProvide input and assist in change control assessment and Part 11 assessment for validated systems\n\nReview Standard Operating Procedures (SOPs) and ensure the operational parameters described in the SOP for the equipment reflect validated conditions\n\nAssist department manager on other types of projects/managerial responsibilities as needed\n\nSchedule and manage routine instrument PM processes\n\nOccasional overnight travel by land and/or air may be required to attend seminars or conferences or client meetings\n\nPerform other duties as assigned\n\nMinimum Qualifications:\n\nRequires a BA/BS in Science (such as Biology, Microbiology, Biochemistry, Chemistry) or other technologically related field plus 4-5 years' work experience in a biopharmaceutical/pharmaceutical manufacturing environment of which 3 years were directly involved in validations.\n\nMust have knowledge of validation principles, standard concepts, practices, procedures and requirements in a GMP regulated environment.\n\nAn understanding of Good Automated Manufacturing Practice (GAMP), SDLC, Risk Assessment and 21 CFR Part 11 Electronic Records and Electronic Signatures required.\n\nPosition Type/Expected Hours of Work:\nThis role is a full-time onsite position. Days and hours of work are Monday through Friday unless otherwise stated by Supervisor. The employee must also have the ability to work overtime and/or weekends when necessary.\n\nCompensation:\nWe offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.\n\nThe compensation range for this role is $105,000 - $124,000 annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.\n\nWho you are:\n\nYou have a \"bring it on!\" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.\n\nYour written and verbal skills are out of this world, and you communicate with clarity and confidence.\n\nYou have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.\n\nYou are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.\n\nPhysical Demands & Work Environment:\nIn this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 25 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.\n\n#J-18808-Ljbffr","datePosted":"2026-08-13T03:33:52.692Z","dateModified":"2026-08-13T03:33:52.692Z","hiringOrganization":{"@type":"Organization","name":"Avid Bioservices","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Tustin","addressRegion":"CA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"edd0580384b161007dddb2fa"},"url":"https://jobsearcher.com/jobs/edd0580384b161007dddb2fa"}}