Process engineer jobs in Florence-Graham, CA - 1,426 jobs
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Process Engineer Level 2
Bykowski Equipment and Engineering Co
Process engineer job in Chino, CA
About Bykowski Equipment Co.
Founded in 1967, Bykowski Equipment specializes in engineering solutions, custom fabrication, installations, parts, and services for the food manufacturing industry. We focus on custom sanitary systems for the Food, Beverage, Cosmetics, and Pharmaceuticals sectors. Joining our team means playing a role in our sustained organic growth.
Job Overview
We are seeking a ProcessEngineer knowledgeable in the design and construction of sanitary process piping systems, preferably in the food and beverage manufacturing industry. This role requires a working knowledge of process flow diagrams, P&IDs, BTU heat calculations, pressure drop calculations, piping design, and automation controls integration. Applicants should be able to engineerprocess piping systems with minimal oversight from management.
Key Responsibilities
1. Design and Troubleshoot Process Solutions: Develop innovative solutions and troubleshoot issues within manufacturing processes.
2. Create and Interpret Process Flow Diagrams and P&IDs: Produce detailed PFDs and P&IDs essential for accurate project execution.
3. Design Layouts for Plant Systems: Plan and design comprehensive layouts for plant systems, ensuring efficient space utilization and system integration.
4. Perform Essential Process Calculations: Carry out critical calculations for BTU, heat transfer, and pump sizing, contributing to accurate project cost estimations.
5. Coordinate Site Visits with Clients: Organize and conduct site visits to document and verify current processes, layouts, and to create accurate PFDs.
6. Develop Process Requirements with Clients: Work closely with clients to outline specific process requirements, including flow rates and product viscosity.
7. Keep Clients Updated: Maintain regular communication with clients regarding project progress, lead times, and expected delivery dates.
8. Manage Job Schedules: Efficiently schedule projects to minimize downtime and ensure timely completion.
9. Engineer Conceptual Process Solutions: Conceptualize and design process solutions, expanding from our library of existing designed systems.
10. Troubleshoot Manufacturing Process Issues: Identify and solve problems within the designed processes, ensuring optimal operation.
11. Create Detailed Process Descriptions and Operation Sequences: Document processes and operational steps to provide clear instructions for project execution.
12. Design and Develop Comprehensive 2D P&ID Flow Diagrams and 3D Models: Utilize design skills to create detailed diagrams and models for project planning and implementation.
13. Produce Drawing Packets and Design Parts for CNC Operations: Prepare necessary documentation and designs for manufacturing and assembly.
14. Provide Instructions to Shop Fabricators: Offer guidance and support to fabricators under the supervision of the engineering manager ensuring that fabrications align with construction drawings and project standards.
15. Engage with Vendors for Cost-effective Solutions: Collaborate with vendors to obtain the best pricing and solutions for project components.
16. Estimate Labor Costs and Manage Project Timelines: Oversee budgeting and scheduling to ensure projects are completed within scope and on time.
17. Utilize ERP System for Equipment Pricing: Use our ERP system to determine the pricing of parts depicted in drawings, aiding in the pricing of systems for sales proposals to customers.
QualificationsRequired
• Bachelor of Science Degree in Mechanical Engineering, Chemical Engineering, or an equivalent of 4 years of related processing industry experience.
• Experience in mechanical drafting using AutoCAD, Plant 3D, and Inventor (or equivalent).
• Must have experience in Microsoft Office programs.
• Knowledge of creating a P&ID Process Flow Diagram.
• Knowledge of process design or piping design for liquid-based sanitary processing systems.
• Knowledge of Fluid Dynamics and fluid pressure drop calculations for process piping.
• Knowledge of Thermodynamics and heat transfer.
Preferred
• Knowledge of centrifugal, positive displacement pumps, and heat exchanger sizing. (BEECO will train candidates.)
• Exposure to welding/fabrication practices.
• Familiarity with CNC laser and mechanical press brake equipment.
• A strong mechanical aptitude; sharing personal DIY projects is encouraged.
Benefits
• 401(k), Dental, Vision, and Life Insurance.
• Health Insurance (HMO & PPO options), Flexible Spending Accounts.
• Paid Time Off, Sick Time, and Paid Holidays.
• Professional growth and training opportunities.
How to Apply
Interested candidates should visit Indeed.com and search for "ProcessEngineer II at Bykowski Equipment Co." in the Southern California Region to find our listing. Follow the instructions to apply directly or save the job for later application. We look forward to your application and potentially welcoming you to our team.
$108k-144k yearly est. 3d ago
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Process Development Engineer
ACL Digital
Process engineer job in Thousand Oaks, CA
Ideal Candidate: 2-4 years of relevant experience working in drug and animal cells. Strong process knowledge. Experience purifying cells (biologics purifications), drug substance GMP manufacturing.
Previous Client or biotech experience is a plus.
Seeking a Process Development Engineer to join the Drug Substance Technology Engineering team at our Thousand Oaks facility. Providing processengineering support for human therapeutic products in clinical development through commercial production, our mission is to translate developmental processes to commercial reality for patients through scientific expertise and engineering innovation.
The Engineer will apply purification processengineering knowledge in support of technology transfer and clinical/commercial drug substance manufacturing in an innovative manufacturing suite using single-use technology. Will partner with manufacturing, quality, analytical, and bench scientists to support a highly dynamic manufacturing facility.
* onsite a minimum of 3 days a week
**Must have biotech background/experience, plus must have purification experience
$83k-110k yearly est. 2d ago
Senior Transportation Project Engineer: Roadway Design Lead
Internetwork Expert 4.6
Process engineer job in Newport Beach, CA
A leading engineering consulting firm in Newport Beach is seeking a Senior Project Engineer with expertise in transportation and civil infrastructure. Ideal candidates have a Bachelor's degree in Civil Engineering, at least 4 years of relevant experience, and preferably a California P.E. license. The role involves leading technical delivery and mentoring junior staff while contributing to impactful public infrastructure projects. Competitive salary and comprehensive benefits are offered.
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$102k-131k yearly est. 3d ago
Manufacturing Engineering Technician III
Belcan 4.6
Process engineer job in Simi Valley, CA
Job Title: Manufacturing Engineering Technician III
Duration: 06 Months Contract (Potential Temp to Perm)
Pay Rate: $38 - $40/hr. (depending on experience)
Shift Time: 1st Shift: M-F 6am - 2:30pm; 7am - 3:30pm; 8am - 4:30pm (Flexible)
Responsibilities:
Provides expertise in developing new engineering solutions to improve the manufacture of new and existing Client products.
Uses existing procedures to solve standard problems; analyzes information and practices to make judgments.
Effectively exchanges straightforward technical information, asks questions, and checks for understanding.
Participates in the team's manufacturing and development work for new and existing products.
Creates and improves processes, equipment, and tooling that can directly impact the growth efforts of operations.
Works within standardized procedures, requirements, and safety policies to achieve objectives and meet deadlines.
Other responsibilities as assigned.
Consistent exercise of independent judgment and discretion in matters of significance.
Regular, consistent and punctual attendance is required. May need to work nights and
weekends, variable schedule(s) and additional hours as necessary.
Provide support to facilities, and equipment maintenance functions as needed.
Qualifications:
Education: A Secondary Certificate/High School Diploma or equivalent combination of relevant education and work experience that will allow successful performance of job expectations.
Certifications: Vocational training, apprenticeships or the equivalent experience in related field.
Years Experience: Min 5-7 years of relevant experience
Excellent ability to apply a systematic, disciplined, and analytical approach to problem-solving.
Advanced knowledge of industrial systems; electrical, plumbing, mechanical systems, and high pressure compressed gas.
Advanced fabrication and assembly skills including: MIG/TIG welding, sheet metal, pneumatic systems, and test equipment.
Able to read, follow, and create documents, schematics, and blueprints.
Effective interpersonal, verbal, and written communication skills to drive tasks to completion.
Proficient in Microsoft Office and CAD tools.
Highly motivated. Ability to create and maintain project timelines, priorities, and goals.
Maintains organized records of work performed.
Demonstrated teamwork and team-building skills in producing results and meeting
organizational objectives. Able to create and maintain enthusiasm for new and challenging
goals. Serve as a role model by promoting new ideas and positive change
3 'Must Haves':
Advanced fabrication and assembly skills including: MIG/TIG welding, sheet metal, pneumatic systems, and test equipment
Advanced knowledge of industrial systems; electrical, plumbing, mechanical systems, and high-pressure compressed gas
Highly motivated. Ability to create and maintain project timelines, priorities, and goals. Maintains organized records of work performed.
3 'Nice to Haves':
Proficient in Microsoft Office and CAD tools
Serve as a role model by promoting new ideas and positive change
Ability to create and maintain project timelines, priorities, and goals
$38-40 hourly 2d ago
Manufacturing Engineering Technician
Biotalent
Process engineer job in Orange, CA
The Manufacturing Engineering Technician is a hands-on role responsible for supporting the development, improvement, and scaling of assembly and test processes for a Class III medical device. This position serves as a critical link between design and production by supporting process validations, maintaining and troubleshooting equipment, documenting manufacturing processes, and assisting with pilot and low-volume manufacturing operations.
The role requires strong technical aptitude, attention to detail, and a quality-focused mindset. The Manufacturing Engineering Technician works closely with cross-functional teams including Mechanical, Electrical, Biomedical Engineering, Quality, and Operations to support the delivery and scale-up of a regulated medical device in a fast-paced environment. This position requires the ability to work independently with minimal supervision.
Key Responsibilities
This job description reflects the general nature and level of work performed and is not intended to be an exhaustive list of all responsibilities.
Equipment Maintenance and Calibration
Set up, operate, and maintain production and test equipment in accordance with manufacturing instructions and quality standards.
Support equipment qualifications (IQ/OQ/PQ), process validations, and test method validations.
Perform routine maintenance and calibration to ensure optimal equipment performance.
Troubleshoot and resolve equipment issues to minimize downtime.
Build products in compliance with environmental controls, hygiene requirements, procedures, and work instructions.
Develop and support assembly and test fixtures per approved documentation.
Inspect incoming supplier components against quality inspection requirements.
Test, inspect, and measure finished products, components, and devices to verify compliance with functional specifications.
Troubleshoot, adjust, repair, and perform root cause analysis on finished products and components.
Process Support
Assist in the development, optimization, and documentation of manufacturing processes.
Support engineers in implementing process improvements to improve efficiency, quality, and cost.
Assist Quality and Purchasing teams with inventory tracking and documentation.
Support the creation, modification, review, and execution of work instructions, assembly drawings, manufacturing processes, protocols, reports, records, and engineering change documentation.
Quality Assurance
Conduct in-process and final inspections to ensure products meet quality and regulatory requirements.
Document and report nonconformances and defects.
Support failure analysis, root cause investigations, and corrective and preventive actions (NCRs, CAPAs).
Maintain cleanroom and controlled manufacturing environments in compliance with housekeeping, ESD, and 5S standards.
Documentation and Compliance
Maintain accurate records related to equipment maintenance, calibration, and process changes.
Ensure all activities comply with FDA regulations, ISO 13485, and Good Manufacturing Practices (GMP).
Collaboration and Training
Collaborate closely with manufacturing engineers, quality personnel, and production teams to support daily operations.
Provide technical support and training to manufacturing operators on equipment and processes.
Continuous Improvement
Identify opportunities for process, equipment, and workflow improvements.
Participate in Lean Manufacturing, Six Sigma, or continuous improvement initiatives as required.
Qualifications, Knowledge, and Experience
Education and Experience
Associate degree or certification in Engineering Technology, Mechanical Engineering, Biomedical Engineering, or a related field; or equivalent hands-on experience.
Minimum of 3 years of experience in manufacturing, assembly, or production, preferably in medical devices, pharmaceuticals, or other regulated industries.
Skills and Competencies
Strong ability to follow detailed procedures and accurately document work.
Solid understanding of manufacturing processes and quality systems.
Strong verbal and written communication skills.
Ability to work independently and collaboratively in a regulated environment.
Physical Requirements
Ability to perform light material handling tasks, including lifting up to 35 pounds for short durations.
Ability to sit for extended periods, including shifts of 8 hours or more.
Frequent keyboard and computer use.
Willingness and ability to wear cleanroom attire (gown, gloves, mask, etc.) for the duration of assigned shifts.
$47k-72k yearly est. 3d ago
Packaging Engineer
Strategic Employment Partners (Sep 4.5
Process engineer job in Industry, CA
Our client, a private label manufacturer in the CPG foods space, is seeking a Packaging Engineer to join their growing team. This role will involve leading packaging design and development, supporting sourcing and procurement efforts, and managing packaging testing protocols.
Term: Full Time/Permanent
Location: City of Industry (onsite)
Compensation: $90k - $120k/year
Desired Qualifications:
3+ years of experience in a packaging engineering-focused role
Experience designing flexible and rigid packaging elements
Experience with testing protocols (ISTA, ASTM, similar)
Experience in the food/beverage industry is a big plus
Degree in Packaging Engineering, or similar
$90k-120k yearly 19h ago
Air Quality Engineer/Scientist (Environmental Compliance Specialist)
Yorke Engineering, LLC
Process engineer job in Riverside, CA
Join Yorke Engineering, LLC, an Environmental Consulting leader in California that implements Environmental Engineering and Compliance solutions for our clients throughout California. Our mission is to solve environmental compliance problems for industrial and governmental/infrastructure facilities. We are a growing and dynamic organization of highly respected professionals. Yorke Engineering, LLC has assisted over 1,900 client organizations with their Air Quality and Environmental Compliance, Engineering, and Permitting needs. Our philosophy is to efficiently help government and industrial customers with the complex array of environmental laws and regulations. From simple permits to complex agency negotiations, from small companies to the largest of California's organizations, Yorke successfully solves our clients' Air Quality and Environmental challenges. Our team has over 1,000 years of combined environmental experience and consists of engineers and scientists that specialize in Air Quality, Waste, Water, CEQA, Safety, and Industrial Hygiene.
We are looking for a sharp Air Quality Engineer / Scientist
(Environmental Permitting and Compliance Specialist)
to join our team in any of our Southern CA offices (Diamond Bar, Long Beach, Los Angeles, San Juan Capistrano, San Diego, Ventura, or Riverside) during our normal business hours. We offer competitive salaries, a full benefits package including Paid Time Off, Holidays, Full Medical/Dental/Vision, along with a 401k program with a generous company match.
Position Summary:
The Air Quality Engineer / Scientist
(Environmental Permitting and Compliance Specialist)
performs professional engineering work, executing the compliance and permitting functions in relation to Air Quality Regulations and Compliance. This candidate will be reviewing processes and equipment, analyzing permit-related technical and regulatory issues, and communicating those analyses within Yorke, the client organization, with government agencies and with the public at large. The work is challenging, broad in scope, and variable from project to project. The position involves effective communication, decision-making, and time management. The candidate performs other duties as required or assigned.
The candidate qualifications we are seeking include:
5-15 years of work experience in the Air Quality and/or Environmental industry in an engineering role (preferably in a consulting environment);
Experience as an active team member in the environmental services industry as a consultant focusing on:
Process and equipment review;
Air quality permitting under SCAQMD, and other Air Districts, including Title V permitting;
RECLAIM implementation and reporting;
Annual Emissions Reporting;
Air Dispersion Modeling;
Air Quality Assessments including Data Analysis and Emission Inventories;
General Air Quality Compliance for facilities in CA, including problem solving.
Ability to be an active team member on project teams towards project completion within project scope, budget and schedule and ensure quality work product and deliverables;
Ability to work with clients, staff, and regulators through effective communication and expertise by fostering a collaborative environment without losing focus of quality;
Proven track record or desire to engage in successful regulatory work in dealing with the SCAQMD, EPA, CARB and/or other similar regulatory agencies;
Experience or desire to work on-site at client facilities;
Prepare reports and submissions in timely manner;
Experience with handling highly technical data and technical data interpretation;
Highly motivated to continue working in Air Quality environmental field and expand their knowledge and experience;
CA Regulatory/Compliance experience is required.
Job Requirements:
B.S or M.S. degree in Chemical Engineering, Environmental Engineering, or Mechanical Engineering, or other relevant technical degrees from an accredited college (minimum GPA of 3.0);
Ability to work collaboratively in a team fashion, handle several projects at once, prioritize work, and work efficiently;
Desire to learn or developing technical expertise in environmental rules and regulations;
Excellent oral and written communications skills;
Experience in conflict resolution and crisis management;
Track record of successful analysis, interpretation, and application of rules and regulations towards practical solutions;
Ability to think critically and develop solutions;
Software Knowledge:
Strong Microsoft Excel, Word, Outlook, and Powerpoint skills (required);
Microsoft 365 Applications, including Sharepoint (a plus)
EIT, CPP or P.E. (a plus).
$76k-102k yearly est. 3d ago
Packaging Engineer
Prokatchers LLC
Process engineer job in El Segundo, CA
• Packaging support & testing: prepare and set up test requests for new materials/components; evaluate test reports; coordinate Greenpoint data requests.
• Data & documentation: perform project data cleanup, maintain project files and LIMS/PLM inputs; ensure accurate documentation for transfers.
• Sustainability & L4TF initiatives: support team efforts on sustainable materials, recyclability checks and L4TF data collection.
• Project collaboration: follow up on action items, liaise with cross‑functional stakeholders (R&I, Supply Chain, Quality), and support implementation steps from concept to launch.
• Supporting on diverse project work, including data gathering and follow-ups.
• Assist in preparing and setting up test requests for new materials and components.
• Perform data cleanup and organization for project documentation.
• Coordinate requests for Greenpoint data and evaluate test reports to inform project decisions.
• Contribute to L4TF initiatives, supporting sustainability efforts.
• Gain real-time experience by actively participating in project development steps, from conception to implementation.
Required:
• Currently pursuing or recently completed degree in Packaging/Mechanical/Materials Engineering or equivalent.
• Entry-level (0-1 year) technical support experience or academic project work.
• Mandatory: Business-level English.
$89k-125k yearly est. 2d ago
Packaging Engineer
Counter 4.3
Process engineer job in Los Angeles, CA
Company: Counter
Job Title: Packaging Engineer
Reports To: Director of Sourcing and Director of New Product Launches
About Us
We are a startup revolutionizing beauty with a purpose; create the industry standard of “clean”. Our premium skincare, makeup, and body care formulations combine uncompromising safety, efficacy and environmental responsibility. And our vision transcends products. We are committed to inspiring confident women and others to recognize their collective power to create meaningful change. Our innovative community-commerce ecosystem connects customers, beauty enthusiasts, and loyalists, allowing each person to align with our brand in ways that authentically reflect their values and aspirations. From our formulas to our advocacy efforts to our community connection, we lead clean.
The Role
The Packaging Engineer will be responsible for developing, sourcing, and executing high-quality, cost-effective packaging solutions that meet brand, quality, and sustainability standards. This role partners closely with cross-functional teams, including Product Development, Operations, and Sourcing, to support new product launches and ongoing production needs.
The Packaging Engineer will oversee component development, supplier management, and production readiness while driving process improvements to enhance efficiency and reduce costs.
Key Responsibilities
Packaging Development & Engineering
• Translate creative design concepts into functional, manufacturable, and cost-effective packaging solutions
• Collaborate with Design, Product Development, and Sourcing to ensure packaging aligns with brand standards, functionality, and cost objectives
• Interpret and approve engineering documents, including die lines, material specifications, and technical drawings
• Provide subject-matter expertise to ensure packaging feasibility and production readiness
• Lead design reviews and recommend improvements to enhance sustainability, quality, and efficiency
• Oversee tooling development, including status tracking, vendor coordination, and cost management
Supplier Management & Sourcing
• Lead supplier evaluations, RFQs, and cost of goods (COGs) analyses to ensure quality, value, and timely delivery
• Build and maintain strong relationships with packaging vendors and contract manufacturers
• Identify cost drivers and apply a total cost of ownership approach to decision-making
• Manage packaging component orders and monitor supplier performance for cost, quality, and delivery
• Conduct on-site visits for supplier assessments, color matching, and first production runs as needed
Production Planning & Quality Assurance
• Coordinate with suppliers and internal teams to ensure on-time delivery of packaging components for production and new product launches
• Oversee packaging inventory levels to support production planning and business continuity
• Support first production runs through on-site quality assurance and troubleshooting
• Collaborate cross-functionally with Supply Chain, Planning, and Logistics to ensure readiness for on-time launches
• Drive initiatives to reduce waste, streamline processes, and improve overall packaging sustainability
Process Improvement & Cross-Functional Collaboration
• Develop and implement best-in-class packaging development processes, documentation, and tools
• Partner with Product Development, Regulatory, Planning, Finance, and Logistics to ensure seamless cross-functional alignment
• Champion continuous improvement initiatives and contribute to operational excellence
• Support packaging technology transfers and process standardization across product lines
Qualifications Required
• Bachelor's degree in Packaging Science, Industrial Design, Engineering, or a related field
• 5-6+ years of experience in packaging development, preferably within the beauty, skincare, or consumer goods industry
• Strong knowledge of packaging materials, manufacturing processes, and structural engineering principles
• Proven experience conducting RFQs, COGs analyses, and managing supplier relationships
• Excellent communication, organization, and project management skills
• Advanced Excel proficiency and familiarity with ERP systems (e.g., NetSuite, SAP, Oracle)
• Ability to work independently and collaboratively in a fast-paced, high-growth environment
Preferred
• Experience with sustainability initiatives and waste-reduction strategies
• Knowledge of clean beauty standards and eco-conscious materials
• Familiarity with PLM systems and technical documentation best practices
• Willingness to travel for supplier meetings, production evaluations, and quality reviews
Counter is a people-powered movement that starts with those behind it! We're building a team that reflects the diversity of the communities we serve, where every individual is respected, supported, and empowered to thrive.
We know that different backgrounds, identities, and perspectives make us stronger, more creative, and better equipped to drive change. That's why we're committed to fostering an inclusive culture where everyone belongs.
Counter is proud to be an Equal Opportunity Employer. We do not discriminate based on race, color, religion, sex, sexual orientation, gender/gender identity or expression, age, national origin, disability, veteran status, or any other legally protected status. We encourage all individuals to apply and join us in shaping a cleaner, more inclusive future for all.
$54k-84k yearly est. 1d ago
Quality Engineer
Stevanato Group
Process engineer job in Ontario, CA
Quality Engineer supports all aspects of the Quality Management System, Product Realization and Manufacturing Process Controls. Working with cross functional partners, defines and generates quality control plans, production process controls and procedures. Leads and supports validations including statistical analysis. Engages with customers to address quality issues and define acceptance criteria/attributes.
Essential Job Functions and Responsibilities:
Support the development and manufacturing of medical devices in conformance with applicable ISO 13485 requirements. Responsible for quality planning of all new development programs and design transfers to production.
Ensure policies and procedures comply with regulations and external standards, including software regulations, risk management, and change control.
Interact and form constructive working relationships with all levels of leadership within Quality, Procurement, Marketing, Engineering, and Operations.
Collaborate with Program Managers, ProcessEngineers, and/or Validation Engineers to execute process and equipment qualifications.
Problem Resolution: identification, data collection and trend analysis, reporting, and initiation of corrective and/or preventive action as well as reporting out of Key Metrics.
Identify opportunities and implement solutions to drive continuous improvement in performance metrics.
Investigate customer complaints, corrective actions and trending to drive improvements. * Plan and perform regular audits of quality system and drive system improvements through the Internal Audit and Quality Event Management (CAPA, NCR, Complaint etc.)
Monitoring and improvement of SPC systems, sampling plans and statistical methods. * Back-up and or perform to Head of Site Quality/Supervisor Representative, as assigned.
Plan, prepare, and execute Internal Audits, as assigned.
Participate in Material Review Board and/or Change Control Board as QA representative.
Utilize tools, gauges and other inspection equipment to obtain product specification data * Expert in utilizing hand measurement tools (Caliper, Micrometer, Ruler, Gage Blocks, height gage, etc.).
High Proficiency with PCDMIS inspection software utilizing CMM's: Brown, Sharpe, Hexagon, Smart scope.
Expert with utilizing ANSI Sampling Plans, IQMS, Minitab, Excel and Microsoft Word
High Proficiency in material analysis (i.e. FTIR, Melt Flow Testing, etc.)
Ability to read and decipher blueprints * Proficient in metrology and calibration.
Working knowledge of statistical methods for manufacturing.
Proficient in Geometric Dimensioning and Tolerancing (ANSI Y-14.5)
Requirements:
Minimum Education: five (5) years' experience in a similar field. Working knowledge in problem solving methodologies. Excellent oral and written communication skills.
Minimum Experience: At least two (2) year experience in a supervision and/or management role. Demonstrated experience to lead teams and projects. Good organizational skills. Previous experience in plastic injection molding related environment.
Demonstrated experience to lead teams and projects. Good organizational skills. Previous experience in plastic injection molding related environment.
Working in a medical device or other FDA regulated industry. Comprehensive understanding of ISO 9001, ISO 13485, JPAL MHLW Ordinance 169, and/or FDA QSR regulatory requirements. Computer literate with working knowledge of MS Word, Excel, and Access.
Desired candidate will have prior work history in MSA, SPC, Mini-tab, Infinity, sterilization, & clean room environment. *Knowledge, Skills, and Abilities
A working knowledge of FDA cGMP, ISO13485 requirements
A working knowledge of medical device manufacturing quality systems.
Working knowledge of Statistical Methods used in manufacturing. * PC-DMIS knowledge a plus.
Education and/or Experience:
3-7 Years in Quality Engineering in manufacturing and/or quality assurance.
Training in applicable ISO 9001, ISO 13485.
Experience using Minitab.
Proficient in metrology and calibration standards.
Proficient in Quality Audit concepts.
FDA quality standards experience a plus.
Certifications such as ASQ CQE, CQA, CQM
Warehouse areas (limited)
Will be required to perform other duties as requested, directed or assigned.
$77k-102k yearly est. 4d ago
Cost Engineer
Myers & Sons Construction 4.4
Process engineer job in Los Angeles, CA
We are currently looking for a Cost Engineer (Cost Controls Engineer) for projects in the greater Los Angeles Area.
We are looking for a person that is capable of developing a deep understanding of the project documents, including; the contract with the owner, subcontracts, cost reports and specifications. This person should feel comfortable navigating and working within accounting and project documentation software, be detailed oriented with experience in the construction industry. The position is directly accountable for the financial performance and reporting, document control and project controls on site.
This position will integrate with the project controls team that focuses, project cost and quantity reports, schedule development, procurement, equipment efficiencies, document control, and as-builts preparation & coordination. Your role on the structures team will depend on your desires as well as strengths and previous experience. You will need to develop and maintain strong relationships with other project engineers and managers, subcontractors, suppliers, and owner representatives.
Key Responsibilities:
Work on-site to help solve problems that occur during construction
Develop and maintain thorough understanding of the contract, focusing on cost control requirements
Monitor project costs and Job Cost Report
Analyze and forecast monthly Total Cost Projection reports
Cost compilation and tracking of extra work, contingencies, allowances, issues
Develop and maintain tracking spreadsheets and documents
Identify and implement strategies for enhanced cost control and tracking methods
Participate in document control and tracking such as submittals, RFI's, and change management
Collaborate and interface with project teams to facilitate proper cost and extra work tracking and billings
Establish and maintain strong, professional relationships with the project team members to ensure clear communication, alignment on project goals, and proactive issue resolution.
Qualifications:
Bachelor's Degree in Engineering, Construction Management, or Business preferred
2+ Years of Experience in highway or roadway construction projects in California.
Experience dealing with engineering or construction cost controls
Excellent organizational, team management, problem solving, motivational skills.
Apply Here: *******************************************************************************
Benefits:
Health Insurance (Medical/Dental/Vision)-our company covers 80% of the healthcare cost for our employees and their dependents. Employees are responsible for the remaining 20%, which is pre-taxable.
Company Vehicle or Vehicle Allowance
Company Cell Phone or Allowance
Flexible Spending Account (FSA)/Dependent Care FSA
401K with 8% Match
Life insurance
Employee Assistance Plan (EAP)
Voluntary insurance plans available-Accident/Critical Illness/Cancer/Hospital Indemnity/Life and AD&D
Paid time off
Professional development assistance
Work in a collaborative environment that fosters creativity, support and mutual respect.
Myers & Sons Construction is proud to be an equal opportunity and affirmative action employer regardless of race, color, gender, age, sexual orientation, gender identity, religious beliefs, marital status, genetic information, national origin, disability, or protected veteran status
$72k-102k yearly est. 4d ago
Manufacturing Test Engineer
Motion Recruitment Partners LLC 4.5
Process engineer job in Costa Mesa, CA
Job Title: Manufacturing Test Engineer (Electrical)
Engagement Type: 1-Year Contract (with possible extension)
Pay Rate: $26-$32.00/hour
Schedule: Monday-Friday | 100% Onsite | 6:00 AM-2:00 PM (PST)
Position Overview
We are seeking a Test Equipment Technician to support manufacturing and test engineering operations at our Costa Mesa facility. This is an immediate need role focused on the maintenance, troubleshooting, and repair of test fixtures and equipment in accordance with Schneider Electric test engineering and quality standards. The ideal candidate will have a strong electrical engineering background, hands-on test experience, and exposure to high-voltage systems.
Key Responsibilities
Perform detailed maintenance, troubleshooting, and repair of test fixtures and test equipment
Ensure all test equipment is properly maintained, calibrated, and operational
Collaborate closely with Test Engineers to diagnose issues and resolve equipment failures
Execute preventive and corrective maintenance tasks to maximize equipment availability, efficiency, and effectiveness
Support workflow scheduling and complete required administrative documentation
Ensure assigned tasks are completed accurately and within established timelines
Adhere to all quality, safety, and engineering procedures
Perform other related duties as assigned
Required Qualifications
Associate degree (AA/AS) in Electrical Engineering or Electrical Technology and 4+ years of related experience
OR
Certificate from a recognized technical trade school (or advanced military technical training) plus 4+ years of related experience
OR
High School Diploma or GED (required) with equivalent hands-on technical experience
Strong hands-on experience with test equipment and electrical systems
Ability to use electronic test and measurement equipment, including DVMs and oscilloscopes, and accurately interpret results
Proficiency with basic hand tools and soldering techniques
Strong written and verbal communication skills in English
Basic computer proficiency, including Microsoft Word and Excel
Good color vision for identifying color-coded wiring and cabling
Preferred Qualifications
Experience working with high-voltage systems (up to 480V)
Manufacturing or test environment experience
Electrical Engineering (EE) background
Top Skills
Test Equipment Maintenance & Troubleshooting
Electrical Engineering Fundamentals
High-Voltage Testing (480V preferred)
Test Fixtures & Manufacturing Test Systems
$26-32 hourly 5d ago
Process Development Senior Associate - Cellular Sciences - Biosafety Development Group
Amgen 4.8
Process engineer job in Thousand Oaks, CA
**Join Amgen's Mission of Serving Patients** At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
**Process Development Senior Associate - Cellular Sciences - Biosafety Development Group**
**What you will do**
Let's do this! Let's change the world!
In this vital role you will join our Biosafety Development (BSD) group.
The Senior Associate will support ensuring patient safety by performing sterile filtration validation studies for Amgen's pharmaceutical products. Also, they may partake in technology development for detection and identification of bacterial adventitious agents.
Primary focus will be on performing GMP validation studies for sterile filtration via Standard Operating Procedures and qualified detection methods using model bacterial strains. These studies will support IND and MA filings to the FDA. Test articles are generated with protein purification processes and will require preliminary testing to assess matrix interference with bacterial health. Assays performed for the detection of bacteria may include traditional detection methods and/or molecular techniques.
**Responsibilities may include the following:**
+ Leading and executing GMP bacterial filtration retention studies to support IND and MA filings to the FDA.
+ Utilizing traditional or molecular assays for the detection of bacterial adventitious agents.
+ Applying filtration knowledge and techniques to troubleshoot problems during execution of studies.
+ Assay method development and qualification.
+ Training other employees.
+ Managing materials and supply inventory.
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a collaborative partner with these qualifications.
**Basic Qualifications:**
+ High school diploma / GED and 6 years of Scientific experience OR
+ Associate's degree and 4 years of Scientific experience OR
+ Bachelor's degree and 2 years of Scientific experience OR
+ Master's degree
**Preferred Qualifications:**
+ Hands on experience with purification processes, especially filtration. Previous work assessing and validating filtration loading and performance using small-scale model devices is desired.
+ Hands on experience with bacterial detection techniques, including molecular biology methods (e.g., qPCR); method development experience a plus.
+ Possess strong written and verbal communication skills and a desire to learn new scientific concepts.
+ Work as a member of a small team to follow and develop methods.
+ Demonstrate good planning and project execution skills.
+ Clearly and concisely interpret and present data.
+ Ability to understand, apply and evaluate biological and mathematical principles.
+ Excellent sterile technique.
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
+ A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
+ A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
+ Stock-based long-term incentives
+ Award-winning time-off plans
+ Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
**Apply now and make a lasting impact with the Amgen team.**
**careers.amgen.com**
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
**Sponsorship**
Sponsorship for this role is not guaranteed.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
$72k-87k yearly est. 3d ago
Engineer, Complaints Investigation Medical Devices (JP11459)
3 Key Consulting
Process engineer job in Thousand Oaks, CA
Business Unit: Complaints Investigations Employment Type: Contract Duration: 12 months (with likely extensions and/or conversion to permanent!) Rate: $37 - $43/hour W2
Posting Date: 5/17/23
Notes: Only qualified candidates need apply. Local candidates only. Onsite 80% of time.
3 Key Consulting is recruiting an Engineer for a consulting engagement with our direct client, a leading global biotechnology company. automotive manufacturing and services company.
Job Description:
Our client is currently seeking a complaints investigation technical investigator in our Complaints Trending and Investigation group. This position will report to Sr Manager in Complaints Trending and Investigation group.
The complaints investigation technical investigator will perform the device assessment of complaint samples using equipment such as the CT scanner, SEM material analysis, and Instron testing machines. S/he will be responsible for authoring the assessment report and communicating the findings and results to management and cross-functional team as required. S/he will be responsible for the validity and integrity of the evaluation reports. The Technical Investigator will maintain close interaction with the quality complaints owner. Additional responsibilities include supporting investigations by performing characterization testing, data gathering and analysis as well as supporting/leading root cause analysis.
S/he will also support the implementation, validation, and operation of the equipment in the CT&I lab, providing personnel training on the use of the equipment, developing and updating equipment procedures, participating in the monthly lab safety inspection, and identifying and reporting equipment repairs or maintenance. S/he will work with the vendor to resolve issues and suggest improvements associated with the operation of the equipment.
Top Must Have Skill Sets:
Experience in technical investigation and root cause analysis
Master's or Bachelor's in Engineering, Science or Biomedical
Experience in lab environment
Able to collaborate and communicate with cross functional team
Day to Day Responsibilities:
Perform device assessments of complaints and document results in a report.
Perform root cause analysis investigations for mechanical and/or electromechanical products
Complete evaluation and deliver assessment report on time per client requirements.
Support the implementation and management of the lab infrastructure, including all equipment used for investigations
Provide requirements for lab and investigational equipment to device development teams in support of new device platforms
Support characterization testing and data gathering for investigations
Basic Qualifications:
Master's degree; OR
Bachelor's degree and 2 years of related medical/biopharma development or Operations experience; OR
Associate degree and 6 years of related medical/biopharma development or Operations experience.
Preferred Qualifications:
Master's or Bachelor's in Engineering, Science or Biomedical
2+ years of experience in complaints investigation within a development, manufacturing, post-market or equivalent environment
Experience in lab environment
Demonstrated competency in root cause analysis methodology
Experience with assessment writing, process and test development and execution, and writing standard operating procedures (SOP)
Strong technical writing and interpersonal skills
Results-driven and detail-oriented
Why is the Position Open?
Supplement additional workload on team.
Red Flags:
No technical background or experience
Lack of basic technical qualifications and must have skills
Inability to commute to Thousand Oaks Facility
Interview Process:
Phone screening (15-30 min with hiring manager)
Video call / interview with cross-functional team (3-4 members, 30 min each)
We invite qualified candidates to send your resume to **************************. If you decide that you're not interested in pursuing this particular position, please feel free to take a look at the other positions on our website ******************************* You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
Regards, 3KC Talent Acquisition Team
$37-43 hourly Easy Apply 60d+ ago
Packaging Engineer
ACL Digital
Process engineer job in Thousand Oaks, CA
This position reports into the Packaging Engineering group under Combination Product Operations (CPO) and is located in Thousand Oaks, CA.
The position will support global supply, new product introductions, partnerships/acquisitions and combination products.
This position will apply engineering principles to implement the accurate design, qualification and implementation of Primary and Secondary Packaging components and the associated systems such as documentation, equipment, and processes.
A knowledge of common materials utilized in healthcare packaging is key to this role.
Material knowledge of structural components are integral in the day-to-day oversight of this role: bottles, labels, trays, lidding material, leaflets, paperboard, sterile barrier packaging, corrugate, etc.
The position entails interpersonal, project management, technical problem solving and communication (written and verbal) skills, and the opportunity to work in teams and adapt to a continuously evolving environment.
Top 3 Must Have Skill Sets:
Packaging Engineering experience, Packaging education, GMP experience
$90k-127k yearly est. 19h ago
Cost Engineer
Myers & Sons Construction 4.4
Process engineer job in Los Angeles, CA
We are currently looking for a Cost Engineer (Cost Controls Engineer) for projects in the greater Los Angeles Area.
We are looking for a person that is capable of developing a deep understanding of the project documents, including; the contract with the owner, subcontracts, cost reports and specifications. This person should feel comfortable navigating and working within accounting and project documentation software, be detailed oriented with experience in the construction industry. The position is directly accountable for the financial performance and reporting, document control and project controls on site.
This position will integrate with the project controls team that focuses, project cost and quantity reports, schedule development, procurement, equipment efficiencies, document control, and as-builts preparation & coordination. Your role on the structures team will depend on your desires as well as strengths and previous experience. You will need to develop and maintain strong relationships with other project engineers and managers, subcontractors, suppliers, and owner representatives.
Key Responsibilities:
Work on-site to help solve problems that occur during construction
Develop and maintain thorough understanding of the contract, focusing on cost control requirements
Monitor project costs and Job Cost Report
Analyze and forecast monthly Total Cost Projection reports
Cost compilation and tracking of extra work, contingencies, allowances, issues
Develop and maintain tracking spreadsheets and documents
Identify and implement strategies for enhanced cost control and tracking methods
Participate in document control and tracking such as submittals, RFI's, and change management
Collaborate and interface with project teams to facilitate proper cost and extra work tracking and billings
Establish and maintain strong, professional relationships with the project team members to ensure clear communication, alignment on project goals, and proactive issue resolution.
Qualifications:
Bachelor's Degree in Engineering, Construction Management, or Business preferred
2+ Years of Experience in highway or roadway construction projects in California.
Experience dealing with engineering or construction cost controls
Excellent organizational, team management, problem solving, motivational skills.
Apply Here: *******************************************************************************
Benefits:
Health Insurance (Medical/Dental/Vision)-our company covers 80% of the healthcare cost for our employees and their dependents. Employees are responsible for the remaining 20%, which is pre-taxable.
Company Vehicle or Vehicle Allowance
Company Cell Phone or Allowance
Flexible Spending Account (FSA)/Dependent Care FSA
401K with 8% Match
Life insurance
Employee Assistance Plan (EAP)
Voluntary insurance plans available-Accident/Critical Illness/Cancer/Hospital Indemnity/Life and AD&D
Paid time off
Professional development assistance
Work in a collaborative environment that fosters creativity, support and mutual respect.
Myers & Sons Construction is proud to be an equal opportunity and affirmative action employer regardless of race, color, gender, age, sexual orientation, gender identity, religious beliefs, marital status, genetic information, national origin, disability, or protected veteran status
$72k-102k yearly est. 4d ago
Process Development Senior Associate - Cellular Sciences - Biosafety Development Group
Amgen 4.8
Process engineer job in Thousand Oaks, CA
Career CategoryScientificJob Description
Join Amgen's Mission of Serving Patients
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Process Development Senior Associate - Cellular Sciences - Biosafety Development Group
What you will do
Let's do this! Let's change the world!
In this vital role you will join our Biosafety Development (BSD) group.
The Senior Associate will support ensuring patient safety by performing sterile filtration validation studies for Amgen's pharmaceutical products. Also, they may partake in technology development for detection and identification of bacterial adventitious agents.
Primary focus will be on performing GMP validation studies for sterile filtration via Standard Operating Procedures and qualified detection methods using model bacterial strains. These studies will support IND and MA filings to the FDA. Test articles are generated with protein purification processes and will require preliminary testing to assess matrix interference with bacterial health. Assays performed for the detection of bacteria may include traditional detection methods and/or molecular techniques.
Responsibilities may include the following:
Leading and executing GMP bacterial filtration retention studies to support IND and MA filings to the FDA.
Utilizing traditional or molecular assays for the detection of bacterial adventitious agents.
Applying filtration knowledge and techniques to troubleshoot problems during execution of studies.
Assay method development and qualification.
Training other employees.
Managing materials and supply inventory.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a collaborative partner with these qualifications.
Basic Qualifications:
High school diploma / GED and 6 years of Scientific experience OR
Associate's degree and 4 years of Scientific experience OR
Bachelor's degree and 2 years of Scientific experience OR
Master's degree
Preferred Qualifications:
Hands on experience with purification processes, especially filtration. Previous work assessing and validating filtration loading and performance using small-scale model devices is desired.
Hands on experience with bacterial detection techniques, including molecular biology methods (e.g., qPCR); method development experience a plus.
Possess strong written and verbal communication skills and a desire to learn new scientific concepts.
Work as a member of a small team to follow and develop methods.
Demonstrate good planning and project execution skills.
Clearly and concisely interpret and present data.
Ability to understand, apply and evaluate biological and mathematical principles.
Excellent sterile technique.
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
Apply now and make a lasting impact with the Amgen team.
careers.amgen.com
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Sponsorship
Sponsorship for this role is not guaranteed.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
.
Salary Range
86,613.00 USD - 104,742.00 USD
$72k-87k yearly est. Auto-Apply 4d ago
Engineer, Medical Combination Devices (JP11777)
3 Key Consulting
Process engineer job in Thousand Oaks, CA
Business Unit: Combination Product Development Employment Type: Contract Duration: 1+ years (with possible extensions) Rate: $38 - $42/hour W2
Notes: Only qualified candidates need apply. Local candidates only. Should be standard hours Monday to Friday
in Office to support Denmark 2 times a week may be expected to be on call at 6 am. can be done remote, but would come to site after call.
3 Key Consulting is recruiting an Engineer for a consulting engagement with our direct client, a leading global biotechnology company.
Job Description:
Note: Not interested in remote only candidates. Should be standard hours Monday to Friday in Office to support Denmark 2 times a week may be expected to be on call at 6 AM PST. Can be done remote, but would come to site after call. Time on campus will be lab work and will be working with lab equipment. There is hybrid opportunity once candidate is seen to be self-sufficient.
Ideal candidate, Familiarity with medical device engineering and applicable standards, preferably ISO 11608-1, and their application.
The Mechanical Engineer on the Combination Product Test Team will interact with global and cross-functional members from systems engineering, processengineering, device development, packaging, primary containers, device quality, and other groups. Responsibilities of this position include development, testing, transfer, and life cycle management of multiple autoinjector device commercialization efforts. Test activities will include Engineering, characterization and GMP verification testing and will require a strong proficiency in developing test protocols, statistical analysis, executing hands on testing, and reporting of results to senior leadership.
This position will work side by side with experienced Device Test Engineers authoring test protocols, executing test plans, performing data analysis, and finalizing test reports. The successful candidate will employ engineering skills and practices to gather user requirements and translate them into technical documentation for test execution and analysis. The position involves support of senior staff in the initiation, design, and delivery of projects milestones to support verification testing activities.
The chosen candidate will frequently spend time in a lab environment working with various types of testing equipment from manual measuring equipment through fully automated testing systems. The devices that will be tested include various iterations of handheld autoinjector drug delivery systems.
This role will include numerous collaboration sessions with the test team and global team to trade best practices, discuss issues and resolutions, and create a testing strategy. The chosen candidate may also take part in design and fabrication of test fixtures and processes.
Top Must Have Skill Sets:
Strong writing and technical authorship including experience in writing test protocols, statistical data analysis, data verification, and test reports for a technical audience including regulatory agencies.
Experience working independently to execute test procedures and operate lab equipment (such as analytical balance, tensile tester, and other automated test equipment) while documenting results according to good documentation practices.
Familiarity with medical device engineering and applicable standards, preferably ISO 11608-1, and their application.
Day to Day Responsibilities:
(50%) Technical authorship of test protocols and reports to support characterization and verification activities. Technical documentation (Test Plans/Protocols/Reports, Engineering Assessments, Design outputs, test-lab equipment/process/control)
(30%) Hands on execution of test protocols in a lab environment, operating test equipment to collect data and record data according to good documentation practices. Testing of autoinjector devices, including the safe operation of test equipment
(20%) Statistical data analysis of test results to be included in technical reports.
Basic Qualifications:
Master's degree OR
Bachelor's degree and 2 years of experience OR
Associate's degree and 6 years of experience OR
High school diploma / GED and 8 years of experience
Why is the Position Open?
Supplement additional workload on team.
Red Flags:
Candidates with Software or Electrical engineering these are NOT desired for the role.
No lab experience.
Different industry (not exp of med device).
No mechanical or med device.
Spelling and grammatical errors in resume. Frequent short job durations and job hopping.
Interview Process:
Three to four one-on-one, 30 minute, remote interviews with various team members. Able to start interviewing immediately.
We invite qualified candidates to send your resume to **************************. If you decide that you're not interested in pursuing this particular position, please feel free to take a look at the other positions on our website ******************************* You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
Regards, 3KC Talent Acquisition Team
$38-42 hourly Easy Apply 60d+ ago
Process Development Senior Associate - Cellular Sciences - Biosafety Development Group
Amgen Inc. 4.8
Process engineer job in Thousand Oaks, CA
Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Process Development Senior Associate - Cellular Sciences - Biosafety Development Group
What you will do
Let's do this! Let's change the world!
In this vital role you will join our Biosafety Development (BSD) group.
The Senior Associate will support ensuring patient safety by performing sterile filtration validation studies for Amgen's pharmaceutical products. Also, they may partake in technology development for detection and identification of bacterial adventitious agents.
Primary focus will be on performing GMP validation studies for sterile filtration via Standard Operating Procedures and qualified detection methods using model bacterial strains. These studies will support IND and MA filings to the FDA. Test articles are generated with protein purification processes and will require preliminary testing to assess matrix interference with bacterial health. Assays performed for the detection of bacteria may include traditional detection methods and/or molecular techniques.
Responsibilities may include the following:
* Leading and executing GMP bacterial filtration retention studies to support IND and MA filings to the FDA.
* Utilizing traditional or molecular assays for the detection of bacterial adventitious agents.
* Applying filtration knowledge and techniques to troubleshoot problems during execution of studies.
* Assay method development and qualification.
* Training other employees.
* Managing materials and supply inventory.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a collaborative partner with these qualifications.
Basic Qualifications:
* High school diploma / GED and 6 years of Scientific experience OR
* Associate's degree and 4 years of Scientific experience OR
* Bachelor's degree and 2 years of Scientific experience OR
* Master's degree
Preferred Qualifications:
* Hands on experience with purification processes, especially filtration. Previous work assessing and validating filtration loading and performance using small-scale model devices is desired.
* Hands on experience with bacterial detection techniques, including molecular biology methods (e.g., qPCR); method development experience a plus.
* Possess strong written and verbal communication skills and a desire to learn new scientific concepts.
* Work as a member of a small team to follow and develop methods.
* Demonstrate good planning and project execution skills.
* Clearly and concisely interpret and present data.
* Ability to understand, apply and evaluate biological and mathematical principles.
* Excellent sterile technique.
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
* A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
* A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
* Stock-based long-term incentives
* Award-winning time-off plans
* Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
Apply now and make a lasting impact with the Amgen team.
careers.amgen.com
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Sponsorship
Sponsorship for this role is not guaranteed.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
.
Salary Range
86,613.00 USD - 104,742.00 USD
$72k-87k yearly est. 4d ago
Engineer, Medical Device Test Design and Execution (JP12062)
3 Key Consulting
Process engineer job in Thousand Oaks, CA
Business Unit: Systems Engineering Employment Type: Contract Duration: 1+ years (with possible extensions) Rate: $37 - $41/hour W2
Notes: Only qualified candidates need apply. Onsite in Thousand Oaks Mon through Fri with need to 6:00 AM calls to support Demark time zone twice a week. Time on campus will be lab work will be working with lab equipment. There is hybrid opportunity once candidate is seen to be self-sufficient.
3 Key Consulting is recruiting an Engineer, Medical Device Test Design and Execution for a consulting engagement with our direct client, a leading global biotechnology company.
Job Description:
The Mechanical Engineer on the Combination Product Test Team will interact with global and cross-functional members from systems engineering, processengineering, device development, packaging, primary containers, device quality, and other groups. Responsibilities of this position include development, testing, transfer, and life cycle management of multiple autoinjector device commercialization efforts. Test activities will include Engineering, characterization and GMP verification testing and will require a strong proficiency in developing test protocols, statistical analysis, executing hands on testing, and reporting of results to senior leadership.
This position will work side by side with experienced Device Test Engineers authoring test protocols, executing test plans, performing data analysis, and finalizing test reports. The successful candidate will employ engineering skills and practices to gather user requirements and translate them into technical documentation for test execution and analysis. The position involves support of senior staff in the initiation, design, and delivery of projects milestones to support verification testing activities.
The chosen candidate will frequently spend time in a lab environment working with various types of testing equipment from manual measuring equipment through fully automated testing systems. The devices that will be tested include various iterations of handheld autoinjector drug delivery systems.
This role will include numerous collaboration sessions with the test team and global team to trade best practices, discuss issues and resolutions, and create a testing strategy. The chosen candidate may also take part in design and fabrication of test fixtures and processes.
Our ideal candidate will have familiarity with medical device engineering and applicable standards, preferably ISO 11608-1, and their application.
Top Must Have Skill Sets:
Strong writing and technical authorship including experience in writing test protocols, statistical data analysis, data verification, and test reports for a technical audience including regulatory agencies.
Experience working independently to execute test procedures and operate lab equipment (such as analytical balance, tensile tester, and other automated test equipment) while documenting results according to good documentation practices.
Familiarity with medical device engineering and applicable standards, preferably ISO 11608-1, and their application.
Day to Day Responsibilities:
This position includes three primary responsibilities:
(50%) Technical authorship of test protocols and reports to support characterization and verification activities. Technical documentation (Test Plans/Protocols/Reports, Engineering Assessments, Design outputs, test-lab equipment/process/control)
(30%) Hands on execution of test protocols in a lab environment, operating test equipment to collect data and record data according to good documentation practices. Testing of autoinjector devices, including the safe operation of test equipment
(20%) Statistical data analysis of test results to be included in technical reports.
Basic Qualifications:
Master's degree OR
Bachelor's degree and 2 years of experience OR
Associate's degree and 6 years of experience OR
High school diploma / GED and 8 years of experience
Why is the Position Open?
Supplement additional workload on team.
Red Flags:
Candidates with Software or Electrical engineering these are NOT desired for the role.
No lab experience
Different industry
No mechanical or medical device experience.
Spelling and grammatical errors in resume. Frequent short job durations and job hopping.
Interview Process:
Three to four one-on-one, 30 minute, remote interviews with various team members.
Able to start interviewing immediately.
We invite qualified candidates to send your resume to **************************. If you decide that you're not interested in pursuing this particular position, please feel free to take a look at the other positions on our website ******************************* You are also welcome to share this opportunity with anyone you think might be interested in applying for this role. Regards, 3KC Talent Acquisition Team
How much does a process engineer earn in Florence-Graham, CA?
The average process engineer in Florence-Graham, CA earns between $73,000 and $129,000 annually. This compares to the national average process engineer range of $62,000 to $108,000.
Average process engineer salary in Florence-Graham, CA