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California
Title Sr. Validation Engineer – Carlsbad
Categories California
Salary Up to $120K annually
Location Carlsbad, CA
Job Information

Opportunity

Our Client is seeking a Senior Validation Engineer for the Carlsbad Viral Vector Manufacturing Facility. This position is responsible for developing, reviewing, and executing validation activities, and ensuring that the qualification/validation activities are consistent with user’s and manufacturer’s requirements and site quality standards.

Why Work Here

  • An agile organization relentlessly focused on building on our global technology leadership and establishing a reputation for quality, safety and reliability
  • Honored by Encina Wastewater Authority (EWA) with its prestigious Gold Award, which requires that businesses meet stringent discharge limits and undergo unannounced inspections and sampling
  • Received the “Excellent Performance Award” by the world’s largest dedicated semiconductor foundry, Taiwan Semiconductor Manufacturing Company Limited (TSMC)

Responsibilities

  • Develop and validate autoclave sterilization cycles per current regulatory requirements (EN285, etc.)
  • Develop and maintain sterilization and equipment re-qualification program using risk-based approach
  • Create and execute IQ/OQ/PQ protocols/reports for equipment (Manufacturing and Lab equipment) and utilities (CDA, CO2, HVAC, Water Systems)
  • Perform risk assessments/FMEAs for equipment
  • Act as technical lead for a cross-functional projects
  • Support site expansion project to ensure validation activities are completed per site requirements
  • Work with equipment vendors to define requirements and understand functional specifications

Qualifications

  • Bachelor’s degree in Engineering or related scientific field required; Master’s degree preferred
  • 7+ years of experience with BS / 4+ years of experience with MS
  • 4+ years of experience with Equipment and Sterilization validation including autoclave sterilization
  • IQ/OQ/PQ experience for lab/manufacturing equipment and utilities
  • Working knowledge of current regulatory guidelines and standards
  • Expertise with Quality Risk Management concepts
  • Technical writing skills to create plans/protocols/reports/SOPs for validation projects

Preferred Qualifications

  • Experience in Biologics manufacturing
  • Experience supporting validation projects associated with new facilities/expansion
  • Understanding of principles and concepts of Lean Six Sigma to continuously improve qualification program

Benefits

  • Pay is commensurate with experience, $100K-$120K per year ($50-$60 per hour)
  • Optional participation in benefits plan (medical, dental, vision, 401K, etc.)
  • 1-year contract opportunity with potential for extension or direct hire

Apply

If your skills match the requirements for this exciting opportunity, please send us your resume today.

Matching people to great jobs with our clients since 1995. Let us help you find that next job!

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Title PhD Technology Transfer Scientist – Carlsbad
Categories California
Salary Starting at $120K annually
Location Carlsbad, CA
Job Information

Opportunity

Our Fortune 500 client is currently seeking a PhD Technology Transfer Scientist to join the team at their Carlsbad, CA site.

Responsibilities

  • Work with the process development team as required to define and scale-up production process unit operations that are robust, repeatable, and Current Good Manufacturing Practices (cGMP) compliant
  • Provide process oversight and upstream and downstream technical support/troubleshooting for Engineering and cGMP runs
  • Compile/generate data and background information to provide documentation for the technology transfer package including the generation of SOPs, Item Specification, Batch Records, and reports governing applicable production process
  • Support the Tech Transfer process including but not limited to planning, bill of materials, scale-up on upstream and downstream process parameters, testing methods, specifications, method and equipment validations, raw material sourcing support
  • Provide Engineering run technical evaluation and approve parameter changes and support the documentation required to justify changes for cGMP campaigns
  • Collaborate cross-functionally on various projects, including executing process risk assessments that support Process Development and Tech Transfer; develop, prioritize, and drive continuous improvements and other operational activities that increase safety, reduce operational costs, and accelerate timelines across all production aspects
  • Serve as the Tech Transfer point of contact with clients for various projects
  • Provide technical support during client and regulatory agencies site audits as needed
  • Proactively identify process gaps, perform root cause analysis, and propose solutions
  • Execute hands-on and train manufacturing staff in upstream and downstream unit operations in a cGMP environment

Qualifications

  • PhD in Biochemistry, Chemistry, Chemical Engineering, or other Life Science related field
  • Scale-up unit operations, ordering materials, creating Batch Records, Item Specifications, and SOPs, preparing reports, streamlining processes, interacting with clients, train manufacturing operators on new processes, and support the execution of upstream and downstream unit operations experience under cGMP
  • 3+ years of experience with cGMP manufacturing and Quality Systems within a FDA regulated manufacturing environment
  • 3+ years of Experience with large molecule biopharmaceutical production, viral vector production, mammalian cell culture processes (adherent and suspension), and single use systems is required
  • Innovative approach to problem-solving and integrated view of business/scientific issues
  • Possess a positive, friendly, and professional demeanor
  • Excellent computer, verbal, and written communication skills

Benefits

  • Competitive salary, commensurate with experience
  • Full suite of benefits including Medical, Dental, Vision offered
  • 8 month contract with opportunity for extension or direct hire at this Fortune 500 Employer

Apply

This is a contract position with competitive compensation.  If you have the experience and knowledge it takes to be successful in this role, send us your resume!

Cybertech Recruiting and Staffing is celebrating 20 years of success matching job seekers to job openings!  Our goal is to delight the candidates we come to know.  Consider working with Cybertech, recent winner of #1 Supplier of the Quarter for a fourth time from one our clients.

Connect with us on Facebook, LinkedIn, Twitter and Instagram from www.cyber-inc.com!

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Title Sr. RF/Wireless Engineer – San Diego
Categories California
Salary Up to $105K annually
Location San Diego, CA
Job Information

Opportunity

Our client, a global testing, certification, inspection and training provider, is seeking a Senior RF Test Engineer in San Diego, CA. The selected candidate will perform required testing to specified standards. This is a dynamic position requiring creativity, drive, flexibility, and a desire to serve the customer.

Why Work Here

  • Known around the world for safety and certainty, reliability and impartiality
  • More than 150 years and 24,000 global employees strong
  • One stop solutions provider for six industry sectors
  • Quite likely that multiple products in your household carry their seal of approval

Responsibilities

  • Perform testing per requirements detailed in international wireless standards and test procedures
  • Review test plans and specifications prior to test for products from Industrial, Commercial, Automotive, Medical, Military and Aerospace industries
  • Ensure quality checks are performed as required and documented
  • Prepare high quality technical reports, communicate test results with customers
  • Provide support to customers regarding the application of standards, test procedures, and certification requirements
  • Work with Account Executives and Inside Sales teams to determine customers’ testing requirements

Qualifications

  • Degree in Electrical or Electronics Engineering
  • 5+ years of experience in an RF/Wireless testing facility
  • Proficient with test equipment: Spectrum Analyzer/Receiver, Signal Generator, Power Amplifiers, Oscilloscope
  • Expert test experience with FCC(CFR), ISED Canada (RSS) and the EU(ETSI); Other international markets a plus
  • Expert knowledge of wireless/RF communication systems and protocols for existing and emerging technologies such as Wi-Fi, Bluetooth, GNSS, 4G, mmW and other license-exempt and licensed devices
  • Knowledge of 5G regulatory development is a plus

Benefits

  • Pay commensurate with experience, $95K to $105K per year
  • Direct hire opportunity
  • Paid holidays and vacation
  • Participation in benefit plans (Medical, Dental, Vision, Disability, 401K)

Apply
If your skills match the requirements for this challenging opportunity, please send us your resume today.

Matching people to great jobs with our clients since 1995. Let us help you find that next job!

Connect with us on Facebook, Instagram, LinkedIn, or Twitter from cyber-inc.com!

Apply Now


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