Current jobs related to Sr. Validation Engineer - Fremont - Asahi Kasei
-
Validation Engineer
3 months ago
Fremont, United States Fladger Assoc. Inc. Full timeJob DescriptionJob DescriptionFremont, CAContract Duration: 3-24 monthsRate: NegotiableResponsibilities:Excellent employment opportunity for a Validation Engineer in the Fremont, CA area.Manage and participate actively in all phases of qualification/validation for QC systems such as QC analytical instrument and equipment: commissioning/qualification,...
-
Sr. Industrial Engineer
2 weeks ago
Fremont, United States Amax Engineering Corp. Full timeSr. Industrial Engineer Company: Amax Engineering Corp. Location: Fremont, CA Position Type: Full Time Experience: Unspecified Education: Unspecified Wage $111,072. to $120,000. per year. Send resume to: Amax Engineering Corp.1565 Reliance Way, Fremont, CA 94539
-
Sr. Packaging Engineer, Service
1 week ago
Fremont, United States Tesla Full timeWhat to ExpectTesla is seeking a highly motivated Sr. Packaging Engineer to join our Packaging team in developing world-class designs for use in high volume automation equipment. You will play a key role on the team and will be the one who brings it all together to drive technical execution of packaging projects across several Vehicle and Energy Product...
-
Sr. Test Engineer
2 months ago
Fremont, United States Tessolve Full timeRole: Sr. Test Engineer Location: Fremont, CA Type: Contract Duration: 12 months (w/ possibility of extension) Job Description: Senior Test Engineer responsible for developing test program and design of hardware on ATE (Automated Testing Equipment) for product bring up, characterization and eventual mass production testing of very high performance SOC...
-
Sr. Test Engineer
1 month ago
Fremont, California, United States Tessolve Full timeRole: Sr. Test Engineer Location: Fremont, CA Type: Contract Duration: 12 months (w/ possibility of extension) Job Description: Senior Test Engineer responsible for developing test program and design of hardware on ATE (Automated Testing Equipment) for product bring up, characterization and eventual mass production testing of very high performance SOC...
-
Sr. Systems Engineer
3 months ago
Fremont, United States Aivres Full timeAbout AivresAivres is a leading global data center and cloud computing solutions provider committed to delivering innovative technologies that propel the world’s leading industries to new frontiers. We deliver and deploy robust, performance-optimized, purpose-built platforms to major data centers around the globe.As a Sr. Systems Engineer, you will play a...
-
Sr. Systems Engineer
3 months ago
Fremont, United States Aivres Full timeAbout AivresAivres is a leading global data center and cloud computing solutions provider committed to delivering innovative technologies that propel the world’s leading industries to new frontiers. We deliver and deploy robust, performance-optimized, purpose-built platforms to major data centers around the globe.As a Sr. Systems Engineer, you will play a...
-
Sr. BIOS Engineer
3 months ago
Fremont, United States Aivres Full timeAbout AivresAivres is a leading global data center and cloud computing solutions provider committed to delivering innovative technologies that propel the world’s leading industries to new frontiers. We deliver and deploy robust, performance-optimized, purpose-built platforms to major data centers around the globe.We are seeking a highly skilled and...
-
Sr. BIOS Engineer
3 months ago
Fremont, United States Aivres Full timeAbout AivresAivres is a leading global data center and cloud computing solutions provider committed to delivering innovative technologies that propel the world’s leading industries to new frontiers. We deliver and deploy robust, performance-optimized, purpose-built platforms to major data centers around the globe.We are seeking a highly skilled and...
-
Fremont, United States Tesla Full timeWhat to ExpectThe Sr. Joining Engineer position, reporting to the Joining Engineering Manager, is located at out Fremont Factory location. The primary responsibility of this role is to manage and launch joining engineering projects from design to start of production. The candidate should have expertise and experience in automotive manufacturing with a full...
-
Sr. Process Engineer
2 months ago
Fremont, United States UCT Alumni Association Full timeJoin UCT and be part of the fastest-growing sector in the world! We indirectly touch every semiconductor chip that goes into every smartphone, smart car and device that uses artificial intelligence. This is a critical time for the semiconductor industry and for UCT - as technology evolves, we evolve with it. UCT is a diverse workplace where every talented...
-
Sr. Process Engineer
2 months ago
Fremont, United States Ultra Clean Technology Full timeJoin UCT and be part of the fastest-growing sector in the world! We indirectly touch every semiconductor chip that goes into every smartphone, smart car and device that uses artificial intelligence. This is a critical time for the semiconductor industry and for UCT - as technology evolves, we evolve with it. UCT is a diverse workplace where every talented...
-
Sr. BMC Engineer
3 months ago
Fremont, United States Aivres Full timeAbout AivresAivres is a leading global data center and cloud computing solutions provider committed to delivering innovative technologies that propel the world’s leading industries to new frontiers. We deliver and deploy robust, performance-optimized, purpose-built platforms to major data centers around the globe.As a Sr. BMC (Baseboard Management...
-
Sr. BMC Engineer
3 months ago
Fremont, United States Aivres Full timeAbout AivresAivres is a leading global data center and cloud computing solutions provider committed to delivering innovative technologies that propel the world’s leading industries to new frontiers. We deliver and deploy robust, performance-optimized, purpose-built platforms to major data centers around the globe.As a Sr. BMC (Baseboard Management...
-
Fremont, California, United States TetraMem - Accelerate The World Full timeTetraMem - Accelerate The World is a rapidly expanding and well-capitalized startup focused on pioneering the next generation of computing platforms utilizing innovative ReRAM-based in-memory computing technologies. We are in search of proficient Analog/Mixed-Signal IC Verification Engineers who are passionate about identifying and resolving issues.In this...
-
Sr. Process Engineer
1 month ago
Fremont, United States UCT Alumni Association Full timeJoin UCT and be part of the fastest-growing sector in the world! We indirectly touch every semiconductor chip that goes into every smartphone, smart car and device that uses artificial intelligence. This is a critical time for the semiconductor industry and for UCT - as technology evolves, we evolve with it. UCT is a diverse workplace where every talented...
-
Sr. Process Engineer
4 weeks ago
Fremont, United States Ultra Clean Technology Systems & Svc Inc Full timeJob DescriptionJob DescriptionJoin UCT and be part of the fastest-growing sector in the world! We indirectly touch every semiconductor chip that goes into every smartphone, smart car and device that uses artificial intelligence. This is a critical time for the semiconductor industry and for UCT - as technology evolves, we evolve with it. UCT is a diverse...
-
Sr. Process Engineer
5 days ago
Fremont, United States UCT Alumni Association Full timeJoin UCT and be part of the fastest-growing sector in the world! We indirectly touch every semiconductor chip that goes into every smartphone, smart car and device that uses artificial intelligence. This is a critical time for the semiconductor industry and for UCT - as technology evolves, we evolve with it. UCT is a diverse workplace where every talented...
-
Sr. Quality Engineer
2 months ago
Fremont, United States Cytek Biosciences, Inc. Full timeJob DescriptionJob DescriptionSUMMARY: The Senior Quality Engineer will be representing Quality in product development and product improvement initiative projects. This person will plan and lead Quality Engineering activities and support Engineering, Operations, Supply Chain, Customer Facing and other functions on applicable product quality, design control,...
-
Sr. Environmental Engineer, Air Quality
1 week ago
Fremont, United States Tesla Full timeWhat to ExpectTesla is seeking a dynamic environmental professional to join the Environmental, Health and Safety Team (EHS). The role will support various environmental compliance programs at Tesla’s Fremont Factory in Fremont, CA. Reporting to the Environmental Affairs Manager, the Sr. Environmental Engineer will be responsible for performing complex...
Sr. Validation Engineer
2 months ago
Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client problems. Because our success depends on our ability to exceed our clients' expectations, we look for candidates with an innate desire to serve. Adaptability and an interest in transformative action are also common attributes among our team. Bionova became a subsidiary of Asahi Kasei Medical in May 2022, a division of Tokyo-based Asahi Kasei Group. This acquisition has enabled Bionova to greatly accelerate growth of the business, both in capacity of current service offerings and expansion into new service offerings.
Company:
Bionova Scientific LLC
Job Description:
Company Summary:
Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client problems.
Because our success depends on our ability to exceed our clients' expectations, we look for candidates with an innate desire to serve. Adaptability and an interest in transformative action are also common attributes among our team.
Position Summary:
The Sr. Validation Engineer will be responsible for supporting new and ongoing validation activities associated with Bionova Scientific's cGMP Manufacturing Facility in accordance with current regulatory and industry standards. As part of the Q Validation group, you will take a hands-on approach to performing the qualification of equipment, utility systems, facilities, processes and/or automation systems and include tasks such as preparing protocols, analyzing test results, and preparing summary reports. As required, this person may also investigate and troubleshoot problems and propose solutions.
Essential Duties and Responsibilities:
- Authoring, reviewing, approving, and executing development and/or validation protocols (IQ, OQ, PQ) and summary reports, including data analysis
- Retrieve and compile data from electronic sources/databases and paper records
- Participate in execution of development and validation studies
- Ensuring proper execution and GMP documentation according to cGMP and GDP.
- Adheres to established regulations and follows cGMP established by site.
- Assist in writing and revising other documentation including Standard Operating Procedures (SOP), User Requirements Specifications (URS), System Impact Assessments (SIA), Validation Master Plan (VMP), Validation Project Plans (VPP)
- Understanding of GMP documentation and technical writing abilities
- As required, in regulatory submissions and represents validation during inspections from regulatory agencies and client audits
This individual should have a general understanding and application of validation principles, concepts, practices, regulations and standards. They should also be familiar in current Good Manufacturing Practices (cGMPs). Must have working knowledge of facility, manufacturing and laboratory equipment and systems, as well as some knowledge of industry practices. Additionally, an excellent verbal, written and interpersonal communication skills are highly desired.
- Bachelor's degree in a science related or engineering background preferred
- 4+ years of direct validation experience and working in a cGMP manufacturing environment
- Strong technical knowledge of validation principles, Quality Systems, manufacturing, and facility equipment/systems
- Experience with systems such for autoclaves, controlled temperature units, utilities (e.g., WFI, CDA, HVAC), single use bioreactors (SUB), mixers, facility/warehouse, and QC instruments (e.g., HPLC, UPLCs)
- In-depth understanding of current GMP Standards, 21 CFR Part 11, Annex 1/11
- Ability to work individually and in a team environment
- Ability to multitask and prioritize tasks
- Interact well and professionally with diverse group of individuals
- Self-motivated and willing to be proactive in resolving issues
- Familiar with Ellab dataloggers a plus
- Strong analytical and problem solving skills
- Flexibility with work hours to meet business needs
Compensation Range: The base compensation range for this role is between $85, 000 and $110,000. However, the actual compensation may vary depending on your experience and qualifications.
Health Benefits and Program: Bionova offers health benefits at a subsidized rate.
Healthcare, Dental, and Vision insurance
Life Insurance and Disability Program: 100% covered by Bionova.
Retirement Plan (401K) Up to 8% of Employer Match
Paid time off up to two weeks
10 days of Holidays and 5 days of Sick Leave.
As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.
