Engineering Journal Scimago Jobs in Ca

Director of Engineering- New Product Development

Location: San Diego, CA (Onsite)

Relocation Assistance Available

Overview

A leading global medical technology organization is seeking a senior engineering/R&D leader to drive complex product development initiatives within a high-impact device portfolio.

This role is responsible for leading enterprise-level development programs spanning hardware, software, and systems integration. You will serve as the central business and execution owner for new product initiatives, ensuring strategic alignment, operational excellence, and predictable commercial delivery.

This is not a traditional project management role; this is a cross-functional business leadership position with full accountability for results.

Key Responsibilities

Enterprise Program Leadership

• Direct end-to-end development of complex, regulated medical device programs from concept through commercial launch
• Lead cross-functional teams across R&D, Regulatory, Quality, Operations, Marketing, and Service
• Ensure execution aligns with portfolio strategy, revenue targets, and long-term platform growth

Strategic & Business Alignment

• Translate corporate objectives into executable development roadmaps
• Drive prioritization and trade-off decisions to protect timelines and business value
• Present program status, risk posture, and strategic updates to executive leadership

Execution & Operational Excellence

• Establish integrated program plans, milestones, and measurable success criteria
• Manage budget forecasting and resource planning
• Oversee risk management frameworks, mitigation planning, and escalation pathways
• Ensure readiness for design transfer, manufacturing scale-up, and commercial release

Organizational Impact

• Build high-performing, accountable cross-functional teams
• Remove roadblocks and accelerate decision-making
• Mentor emerging leaders across technical and functional groups
• Champion continuous improvement in product development processes

Qualifications

Required

• Bachelor's degree in Engineering or a scientific discipline
• 9+ years of experience in medical device product development or another highly regulated industry
• 5+ years leading complex, cross-functional teams
• Proven track record delivering successful new product launches
• Strong understanding of design controls, quality systems, and regulatory frameworks (FDA experience preferred)
• Experience with design transfer and manufacturing readiness

Preferred

• Advanced degree (MS or PhD)
• Experience leading hardware/software integrated systems programs
• Background in capital equipment or connected medical technologies

Role: Engineering Lead (Java/DevOps)

Location: Burbank, CA - Onsite, Hybrid

1) 8+ years in full-stack development

a. Experience building distributed systems with strong proficiency in Java/Spring Boot, Angular (or React/Vue)

2) DevOps fluency: Proven track record designing and delivering AWS-native architectures (Lambda, API Gateway/AppSync, Step Functions, Event Bridge, DynamoDB/RDS, S3)

a. 8+ years of experience.

3) 8+ years of CI/CD fluency: Hands-on with CI/CD pipelines.

a. (GitHub Actions or AWS Code Pipeline), Infrastructure as Code (CloudFormation/CDK/Terraform), and automated testing frameworks. You help the team maintain stability, automate deployments, and manage the integrity of development across environments (Dev, QA, Prod).

Technology Requirements:

1) Full-Stack Depth & Breadth

Experience building distributed systems with strong proficiency in Java/Spring Boot, Angular (or React/Vue), and AWS-native architectures (e.g., Lambda, Step Functions, Event Bridge, AppSync, DynamoDB).

2) DevOps and Automation Expertise

You've led teams through CI/CD transformations, working with tools like GitHub Actions, AWS Code Pipeline, or Terraform/CDK, and helped establish reliable, repeatable release pipelines

Job Summary:

This role is a hands-on engineering leadership position responsible for driving manufacturing excellence, leading New Product Introductions, and building a high-performing engineering organization. The Director of Engineering & CI plays a critical role in ensuring operational excellence, customer satisfaction, and long-term scalability of the business.

Position Summary:

The Director of Engineering & CI is responsible for leading all engineering, manufacturing process development, and technical execution functions across the organization. This role owns New Product Introduction (NPI), manufacturing process optimization, and engineering team leadership, while ensuring scalable, repeatable, and high-quality manufacturing operations.

This role serves as the technical authority for CNC manufacturing operations and provides leadership over Manufacturing Engineers, CNC Programmers, and cross-functional technical resources. The position ensures that manufacturing methods, tooling, and processes support business growth, cost targets, quality objectives, and on-time delivery.

The role plays a critical leadership function in advancing Lean Manufacturing, improving throughput, reducing variation, and supporting customer and regulatory requirements in an AS9100 aerospace environment. Reporting to the General Manager, the Director Engineering Director and CI will foster a culture of innovation and collaboration across multi-disciplinary teams, ensuring delivery of high-quality results in line with schedule and financial performance targets

Core Responsibilities

New Product Introduction (NPI) Leadership

• Own and lead all New Product Introduction (NPI) activities from engineering release through full-rate production
• Define manufacturing strategy, routing, tooling, and inspection plans for new programs
• Coordinate cross-functionally with Quality, Operations, Supply Chain, and Sales during program launch
• Ensure first-article success, manufacturability, and cost targets are achieved
• Drive rapid and repeatable production readiness

Manufacturing Engineering & Process Excellence:

• Lead development, implementation, and continuous improvement of:
• Manufacturing processes
• CNC machining strategies
• Work instructions and routings
• Tooling and fixturing
• Inspection and quality controls
• Establish standardized, repeatable manufacturing methods across product lines
• Improve throughput, reduce scrap, and improve yield using Lean and Six Sigma principles
• Drive process optimization using PFMEA, control plans, and root cause analysis
• Lead continuous improvement initiatives focused on cost, quality, and delivery

CNC Programming & Technical Leadership:

• Provide leadership and technical oversight to CNC Programmers and Manufacturing Engineers
• Ensure best practices in:
• 3-, 4-, and 5-axis machining
• Multi-spindle and multi-turret turning
• Toolpath optimization
• Program validation and prove-out
• Oversee Mastercam programming standards and documentation
• Ensure tooling libraries, setup sheets, and CNC documentation are accurate and maintained

Team Leadership & Development:

• Lead, mentor, and develop Manufacturing Engineers and CNC Programmers
• Establish training plans, skill development paths, and succession planning
• Conduct performance reviews and KPI-based evaluations
• Foster a culture of accountability, ownership, and continuous improvement
• Serve as a technical mentor and escalation point for complex manufacturing challenges

Manufacturing Strategy & Capacity Planning:

• Define manufacturing strategies to support growth, margin improvement, and scalability
• Optimize labor utilization, machine capacity, and workflow layouts
• Support capital equipment planning and justification
• Collaborate with Operations to balance capacity, scheduling, and throughput
• Support make/buy decisions and vendor technical evaluations

Quality & Compliance Integration:

• Ensure compliance with AS9100 and customer-specific requirements
• Support audits, corrective actions, and continuous improvement initiatives
• Partner with Quality to reduce NCRs, rework, and escapes
• Promote a data-driven, root-cause-focused culture

Cross-Functional & Business Support:

• Support quoting and RFQ efforts with accurate cost and process estimates
• Collaborate with Sales, Supply Chain, Quality, and Operations leadership
• Drive technical execution of strategic initiatives
• Represent Engineering in leadership meetings and program reviews

Qualifications

• Proven experience in leading engineering teams within fast-paced environments; strong management skills with the ability to motivate diverse groups.
• Bachelor’s Degree in Mechanical, Manufacturing, or Aerospace Engineering
• 8–12+ years of experience in aerospace or precision CNC manufacturing
• 5+ years leading Manufacturing Engineers and/or CNC Programming teams
• Strong experience with:
• CNC machining (3-, 4-, 5-axis)
• Mastercam or equivalent CAM software
• GD&T and blueprint interpretation
• Lean Manufacturing / Continuous Improvement
• ERP systems and manufacturing routings
• Demonstrated experience leading New Product Introductions (NPI)
• Strong knowledge of AS9100 quality systems
• Experience implementing Agile methodologies
• Excellent communication skills to articulate complex technical concepts clearly
• Ability to develop strategic plans for business continuity strategies aligned with organizational goals.

Preferred Qualifications:

• Experience with:
• Multi-spindle / multi-turret machining
• High-mix, low-volume aerospace manufacturing
• PFMEA, SPC, and RCCA methodologies
• PMP or Lean Six Sigma certification (preferred)
• Strong background in tooling design and fixture development
• Experience managing engineering teams in regulated environments
• Leadership & team development
• Technical problem-solving
• Manufacturing process optimization
• Data-driven decision-making
• Cross-functional communication
• Continuous improvement mindset
• Strong organizational and project management skills

Join us as at ACRA Aerospace where your expertise will shape innovative solutions that propel our organization forward! We are committed to fostering an inclusive environment that values leadership excellence and technical mastery—empowering you to make a lasting impact through your vision and dedication.

Immediate need for a talented Electrical Engineering 3. This is a 06+months contract opportunity with long-term potential andis located in Santa Clara, CA(Onsite). Please review the job description below and contact me ASAP if you are interested.

Job ID: 26-05995

Pay Range: $58 - $60/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Responsibilities: -

• Designing, developing, optimizing, and maintaining FPGA RTL using Verilog/SystemVerilog and/or VHDL
• Supporting the full FPGA development lifecycle, including synthesis, place-and-route, timing closure, and bitstream generation
• Performing functional simulation, verification, and system-level debugging
• Supporting board bring-up, testing, integration, and validation
• Collaborating closely with hardware, firmware, software, and systems engineering teams
• Documenting design decisions, test results, and process improvements
• Participating in design reviews and regulated development activities

Key Requirements and Technology Experience:

• Key skills; FPGA (FIELD-PROGRAMMABLE GATE ARRAY")/VERILOG, Circuit/semiconductor, Medical device, robotics, medical system industry
• 4+ years of hands-on FPGA design and development experience
• Strong understanding of digital logic, timing analysis, and debugging
• Proficiency in Verilog/SystemVerilog
• Experience with FPGA toolchains such as Xilinx Vivado, Lattice Diamond, or equivalent
• Bachelor’s degree in Mechanical Engineering, Electrical Engineering, or a related scientific field
• Robotics design exposure
• Strong collaboration and communication skill.
• Prior experience in medical devices, robotics, or safety-critical systems
• Exposure to regulated environments such as FDA, IEC, or ISO
• End-to-end FPGA ownership from architecture through validation
• Experience debugging real hardware issues beyond simulation
• Familiarity with high-speed protocols such as PCIe, Ethernet, DDR, or Aurora
• Experience using simulation, verification, and hardware debug tools (logic analyzers, oscilloscopes)
• Cross-functional collaboration with mechanical, systems, or clinical teams

Our client is a leading Healthcare Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.

Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

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Summary

The Manufacturing Engineering Technician III role involves a blend of responsibilities across manufacturing engineering, engineering development, new product introduction (NPI), and tooling design. The successful candidate will be hands-on in the early stages of building new engineering product prototypes, as well as Low Rate Initial Production (LRIP) and Maintenance, Repair, and Overhaul (MRO) builds. This individual support Design for Excellence (DFX), and design and implement tooling and fixtures with the aid of drafting resources. They will ensure that learnings from early product builds are integrated into a production-ready package. This role supports the key step in transitioning new product introductions into mature full-rate production stages. Additionally, the candidate must possess excellent collaboration skills to ensure continuous feedback with various engineering teams and production staff.

Position Responsibilities

• Hands-on building and assembly of early units of new products with engineering support.
• Conduct mechanical, electrical, and composite fabrication, troubleshooting, repair, and testing of integrated systems.
• Ensure a smooth transition from product development to manufacturing, focusing on quality, reliability and cost
• Work effectively with engineering teams and production staff to provide and receive continuous, regular feedback.
• Provide rapid prototyping fabrication and assembly services to build prototype product hardware.
• Design, develop, and implement tooling, including assembly fixtures, fabrication fixtures, and molds.
• Support DFX, cost, and reliability analysis initiatives in collaboration with design engineering teams.
• Develop and maintain manufacturing processes, including creating and updating work instructions, assembly procedures, and supporting documentation.
• Lead efforts in lean manufacturing and Six Sigma methodology to achieve continuous improvement in productivity, quality, and lead times.
• Incorporate lessons learned from NPI and early product builds into efficient production processes.
• Implement ergonomic design considerations to ensure safe, effective, and productive tool usage.
• Maintain shop equipment and tools in a safe, clean, and organized environment for development and production activities.
• Track and report Key Performance Indicators (KPIs), including build linearity and transition rates from NPI to full production.
• Work on problems of diverse scope requiring analysis of identifiable factors.

Basic Qualifications (Required Skills & Experience)

• High School diploma or GED equivalent and/or equivalent certificate from a technical school
• 4-6 years of experience in Manufacturing, Mechanical, Electrical, or Test Engineering, with experience in Aerospace, Automotive, or Commercial industries.
• Experience in Lean Manufacturing principles and Six Sigma methodology.
• Proficiency with electro-mechanical manufacturing and procedures
• Exposure to engineering drawings and Bill of Materials.
• Proficiency in Microsoft Office Suite (Word, Excel, Outlook, PowerPoint) and CAD software (SolidWorks preferred).
• Occasional travel required (up to 10%).

Other Qualifications & Desired Competencies

• Experience in sheet metal fabrication, plastics, composite layups, PCB assembly, mechanical assembly, calibration, and testing processes.
• Strong problem-solving ability, root cause analysis skills, and ability to work independently.
• High levels of initiative, ownership, and responsibility for work products.
• Commitment to continuous learning and improvement.
• Effective time management, analytical, interpersonal, and communication skills.
• Teamwork and collaboration-oriented mindset.

Compensation:

$50-70/hourly

About the Role

As a Front-End Engineering Leader at Petco, you’ll guide the technical vision, architecture, and execution of our customer-facing digital products—including , our mobile web experience, and other connected commerce platforms.

You’ll lead a talented team of front-end engineers, championing best practices in React.js, Node.js, and Next.js, while building performant, accessible, and engaging experiences that help pet parents connect more deeply with their pets.

This is a hands-on leadership role for someone who thrives at the intersection of technical strategy, engineering excellence, and team mentorship.

Key Responsibilities

• Lead the front-end engineering strategy and execution across Petco’s digital ecosystem.
• Define, evolve, and enforce best practices for front-end architecture, component libraries, and performance optimization.
• Collaborate closely with Product, UX, and Backend teams to deliver seamless and scalable user experiences.
• Guide architectural decisions on frameworks, libraries, and tooling—balancing innovation with long-term stability.
• Manage, mentor, and grow a team of front-end engineers; foster a culture of collaboration, learning, and accountability.
• Partner with backend teams on Node.js services and integrations to ensure end-to-end system efficiency.
• Drive initiatives around site performance, accessibility, observability, and maintainability.
• Influence Petco’s technology roadmap and advocate for technical investments that support scalability and innovation.
• Oversee engineering processes to ensure timely and high-quality delivery across multiple cross-functional teams.
• Collaborate with leadership to align technical direction with business goals and customer needs.

Qualifications

• Bachelor’s or Master’s degree in Computer Science, Engineering, or related field—or equivalent experience.
• 12+ years of software engineering experience, with at least 5 years in a technical leadership or management role.
• Deep expertise in React.js, Node.js, and Next.js in high-traffic, large-scale environments (preferably e-commerce).
• Proven experience designing and implementing front-end architecture for modern web applications.
• Hands-on experience with AWS, CI/CD pipelines, and application observability tools.
• Strong understanding of web performance, SEO, accessibility (WCAG), and responsive design principles.
• Excellent communication and influencing skills; able to align technical vision across engineering and business stakeholders.
• Passionate about Petco’s mission—and motivated to build technology that improves lives for pets and their parents.

Why You’ll Love Working Here

• Purpose-driven work that directly impacts the health and happiness of pets and their families.
• A collaborative, inclusive environment where you’re encouraged to bring your whole self to work.
• Opportunities for continuous learning, leadership development, and career growth.
• Competitive compensation, benefits, and perks that support your wellbeing

At Two Bear Capital we believe in partnering with our portfolio companies to build the best teams possible. We look forward to working with you and Rainfall Health on their new Director of Software Engineering role.

Director of Software Engineering (AWS Amplify & Digital Health)

*please note that this role requires willingness to travel to the Bay area and/or relocating to the Bay area

*please note that this position requires US citizenship/does not provide sponsorship

About Rainfall Health

Rainfall Health is an AI-powered compliance and workflow platform helping health systems succeed under CMS’s TEAM Model and other value-based care programs. We partner with hospitals, surgeons, and care teams to improve episode performance, streamline operations, and maximize reimbursement — all while supporting better patient outcomes.

Our platform sits at the intersection of clinical workflows, financial performance, and intelligent automation.

The Role

We are looking for a Director of Software Engineering with deep experience in AWS Amplify and modern cloud-native architectures to help build and scale our digital health platform. You’ll play a key role in designing secure, reliable systems that integrate with healthcare data sources and surface actionable insights to clinical and operational teams.

This role is ideal for someone who enjoys solving complex data and workflow challenges in a regulated healthcare environment.

What You’ll Do

Platform & Application Development

• Design, build, and maintain scalable web applications using AWS Amplify, serverless services, and modern frontend frameworks
• Develop robust APIs and backend services using AWS-native tools (e.g., AppSync, Lambda, DynamoDB, RDS)
• Ensure performance, reliability, and security across distributed cloud systems

Healthcare Data & Integrations

• Build and maintain integrations with Electronic Health Records (EHRs) and other healthcare systems
• Work with healthcare interoperability standards such as FHIR, HL7, and APIs from major EHR vendors
• Design data ingestion pipelines that normalize, validate, and securely store clinical and operational data

Data Visualization & Insights

• Develop interactive dashboards and data visualization tools for clinical and operational users
• Translate complex healthcare data into intuitive, actionable insights
• Collaborate with product and design teams to create user experiences tailored to care teams and administrators

Cross-Functional Collaboration

• Work closely with product managers, designers, and clinical stakeholders to deliver features aligned with real-world workflows
• Contribute to architectural decisions and technical roadmap planning
• Mentor other engineers and promote best practices in code quality, testing, and security

Security & Compliance

• Implement best practices for HIPAA-compliant infrastructure and data handling
• Ensure systems meet high standards for privacy, auditability, and reliability in a healthcare environment

What We’re Looking For

Required:

• 8+ years of software engineering experience building production-grade applications
• Hands-on experience with AWS Amplify and serverless AWS architectures
• Strong experience with modern JavaScript/TypeScript frameworks (e.g., React, Next.js, Vue)
• Experience building and consuming RESTful and/or GraphQL APIs
• Solid understanding of cloud security and best practices for handling sensitive data

Preferred:

• Experience in digital health, healthcare IT, or healthtech startups
• Experience integrating with EHR systems (Epic, Cerner, Meditech, etc.)
• Familiarity with FHIR, HL7, CCD, or other healthcare data standards
• Experience building data visualization tools (e.g., D3, Chart.js, Recharts, or BI tools)
• Knowledge of healthcare compliance frameworks (HIPAA, HITRUST, SOC 2)

Nice to Have

• Experience with real-time data pipelines or event-driven architectures
• Background in analytics, population health, or value-based care technology
• DevOps experience with CI/CD pipelines and infrastructure as code

What Success Looks Like

• Seamless, secure integrations with healthcare systems
• Intuitive dashboards that drive decision-making for clinical and operational teams
• A scalable, maintainable architecture that supports rapid product growth
• Strong engineering culture centered on reliability, security, and user impact

MediaTek Incorporated is a global fabless semiconductor company that enables nearly 2 billion connected devices a year. We are a market leader in developing innovative systems-on-chip (SoC) for mobile device, home entertainment, connectivity and IoT products. MediaTek is the number one Wi-Fi supplier across broadband, retail routers, consumer electronics devices and gaming, and its Wi-Fi 6 chipsets are powering the latest networking equipment for faster computing experiences.

Our dedication to innovation has positioned us as a driving market force in several key technology areas, highly including power-efficient mobile technologies, automotive solutions and a broad range of advanced multimedia products such as smartphones, tablets, digital televisions, 5G, Voice Assistant Devices (VAD) and wearables. MediaTek empowers and inspires people to expand their horizons and achieve their goals through smart technology, more easily and efficiently than ever before. We work with the brands you love to make great technology accessible to everyone, and it drives everything we do. Visit for more information.

Job Description:

We are seeking an experienced and highly skilled Program Leader to spearhead the planning, execution, and delivery of complex projects spanning the domains of data centers and artificial intelligence. This role is technically demanding and requires a strong background in Electrical Engineering and Computer Science to effectively identify and resolve cross-functional technical issues and risks.

Key Responsibilities

• Lead and manage end-to-end program delivery for data center projects, ensuring alignment with business objectives and development timelines.
• Collaborate with internal cross engineering teams and external customers to drive project direction and manage risks.
• Influence and execute across cross-functional engineering and operations organizations, fostering effective communication and teamwork.
• Provide clear and focused project reporting to executives and stakeholders, ensuring transparency and accountability.
• Identify and mitigate program risks, proactively addressing issues to ensure successful implementation.
• Coordinate resources, schedules, and deliverables across multiple teams and locations.
• Maintain strong organizational discipline and strategic thinking to achieve program goals.

Qualifications

• Master’s degree in Electrical Engineering, Computer Science, or a related field; advanced degree preferred.
• Minimum of 8 years of technical experience in program management, preferably within the data center or AI industry.
• Proven track record of delivering complex, multi-disciplinary technical programs.
• Strong leadership skills with the ability to influence and motivate cross-functional teams without direct authority.
• Exceptional organizational, analytical, and problem-solving abilities.
• Proficiency with program management tools and relevant software/hardware (e.g., Jira, MS Project).
• Ability to work effectively across different time zones and in a global team environment.
• Willingness and ability to travel internationally as required.

Salary range: $170K- $250K

MediaTek is an Equal Opportunity Employer that is committed to inclusion and diversity to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (includes pregnancy, childbirth, breastfeeding and related medical conditions), and sexual orientation.

Employee may be eligible for performance bonus, short and long term incentive programs. Actual total compensation will be dependent upon the individual's skills, experience and qualifications. In addition, MediaTek provides a variety of benefits including comprehensive health insurance coverage, life and disability insurance, savings plan, Company paid holidays, Paid time off (PTO), Parental leave, 401K and more.

Job description:

General Engineering Contractor specializing in construction of Water & Sewer related infrastructure seeking qualified applicants for the position of PROJECT ENGINEER.

Responsibilities:

- Receive, log, and prepare for distribution, project related Product Submittals and RFIs

- Updates to critical path method (CPM) schedule

- Maintain log sheets for Submittals, RFIs, and Change Order Requests

- Assist Project Managers with preparation of weekly progress meeting agendas

- Attend and prepare minutes for weekly progress meetings (Office and Field)

- Assist Project Managers with preparation of subcontractor agreement packages & purchase orders

- Prepare material qty takeoffs for earthwork, structural concrete, rough carpentry, and piping systems.

Skills:

- Procore

- CPM Scheduling (P6 & MS Project)

- Skilled in the use of Microsoft Office programs Outlook Email, Excel, & Word

- Clear written and verbal communication

- Strong attention to detail and surroundings

- Blueprint reading, material takeoff, & purchasing

This position offers career advancement opportunities into the position of Assistant Project Manager.

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Education:

• Associate (Required)

Experience:

• Project Engineer: 2 years (Required)

Pay: $70,000.00 - $75,000.00 per year

Automation CSV Engineer (Biotech/Pharma)

Location – California Bay Area

Please note: We are only considering W2 candidates at this time. Applications from third-party vendors or C2C arrangements will not be considered.

ADVENT Engineering is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Headquartered near San Francisco, California, and with operations in the Eastern and Western US, Canada and Singapore, our company is involved in almost every facet of global pharmaceutical and biotechnology facility design and process engineering and quality system projects.

ADVENT's services include process engineering, automation engineering, project engineering, facility/system design, start up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies.

The successful candidate will work with a group of engineers involved in the design, automation, commissioning and start-up of various processes, systems and facilities. A combination of strong technical aptitude, automation engineering skills and technical writing are the desired skill set.

This is an outstanding opportunity to join our growing team!

Position Overview

We are seeking an experienced Sr. Automation CSV Engineer to support a complex automation system migration project at a large, regulated biotechnology/pharmaceutical manufacturing site in the California Bay area. The ideal candidate will bring deep, hands-on expertise in PCS and MES system migration, validation, and implementation, with a strong preference for experience in Rockwell and PharmaSuite environments.

This role requires a senior-level engineer capable of independently executing and leading CSV and automation activities while collaborating closely with cross-functional teams.

Key Responsibilities

• Lead and execute CSV and automation activities for PCS/MES system migration projects
• Support implementation, migration, commissioning, and validation of:
• PCS systems (Rockwell, Honeywell)
• MES systems (PharmaSuite, POMSnet)
• SCADA and PLC platforms
• Author, review, approve, and execute CSV lifecycle documentation, including:
• Validation Plans
• Risk Assessments
• Test Protocols (IQ/OQ/PQ)
• Traceability Matrices
• Validation Summary Reports
• Ensure compliance with SDLC, 21 CFR Part 11, Annex 11, Data Integrity, and GAMP 5
• Manage and document software changes throughout the SDLC per site procedures
• Support programming, configuration, commissioning, and validation of Rockwell and PharmaSuite platforms
• Collaborate with automation, IT, QA, and manufacturing teams
• Support troubleshooting, root cause analysis, and deviation investigations as needed
• Communicate effectively with stakeholders at all levels

Required Qualifications

• 8+ years of experience in CSV and Automation within a regulated biotech/pharma environment
• Hands-on experience with implementation, migration, and validation of:
• PCS (Rockwell and/or Honeywell)
• MES (PharmaSuite, POMSnet)
• SCADA/PLC systems
• Strong, hands-on expertise with Rockwell and PharmaSuite (required)
• In-depth knowledge of:
• SDLC
• 21 CFR Part 11 / Annex 11
• Data Integrity
• Computerized System Validation (CSV)
• Ability to work independently and collaboratively in team environments
• Excellent verbal and written communication skills

Preferred Qualifications

• Familiarity with S88 Batch Standard
• Experience with Rockwell software object development
• MES recipe authoring and testing experience
• Experience with Kneat

Additional Information

• This position requires 100% onsite support in California
• Long-term project opportunity in a regulated manufacturing environment