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Manufacturing Execution System Jobs in Oregon (NOW HIRING)

Tulip Interfaces

OR · On-site

$100K - $145K/yr

... Manufacturing ... Execution System (MES) category. A spinoff out of MIT, Tulip is headquartered in Somerville, MA ...

Aerotek

Assembler

Salem, OR

$16 - $19.75/hr

Accurately record manufacturing and production data using MES (Manufacturing Execution System) software. * Provide recommendations for process improvements to enhance efficiency, quality, and safety ...

New

Deloitte

MES Functional Consultant

Portland, OR · Hybrid

Experience with manufacturing execution system platforms, including Opcenter, Apriso, AVEVA, or FactoryTalk * Experience with ISA-95 or ISA-88 frameworks * Experience supporting Industry 4.0 ...

KWS SAAT SE

Seed Processing Line Operator

Tangent, OR · On-site

$23.28/hr

Operate systems such as Human Manufacturing Interface (HMI) and Manufacturing Execution System (MES) * Train and lead temp labor crews in seed processing functions * Monitor indicators to assess ...

Tulip Interfaces

OR

... Manufacturing Execution System (MES) category. A spinoff out of MIT, Tulip is headquartered in Somerville, MA, with offices in Germany, Hungary, Singapore, and Israel. Tulip has been recognized as a ...

Intel

ORAP Module Equipment Technician

Hillsboro, OR · On-site

... Manufacturing Execution System (MES) software. - Strong attention to detail, safety-conscious mindset, and ability to operate effectively in a dynamic, fast-paced environment. Job Type:Tech Grad ...

Intel

ORAP Module Equipment Technician

Hillsboro, OR · On-site

... Manufacturing Execution System (MES) software. - Strong attention to detail, safety-conscious mindset, and ability to operate effectively in a dynamic, fast-paced environment. Job Type:Tech Grad ...

Benchmade, Inc.

Machining Tech - Swing Shift

Oregon City, OR · On-site

$21.50 - $27.50/hr

Accurately complete production documentation, including Manufacturing Execution System (MES) entries and quality checks. * Follow all safety protocols and maintain a clean, organized, and safe work ...

Benchmade, Inc.

Machining Tech - Swing Shift

Oregon City, OR · On-site

$21.50 - $27.50/hr

Accurately complete production documentation, including Manufacturing Execution System (MES) entries and quality checks. * Follow all safety protocols and maintain a clean, organized, and safe work ...

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Manufacturing Execution System information

What is a Manufacturing Execution System job?

A Manufacturing Execution System (MES) job involves overseeing and managing software solutions that monitor, control, and optimize manufacturing processes on the shop floor. Professionals in this role ensure seamless data flow between production equipment, operators, and enterprise systems to improve efficiency, quality, and compliance. Responsibilities often include system implementation, configuration, troubleshooting, and continuous improvement initiatives. MES roles are crucial in industries like automotive, pharmaceuticals, and electronics, where real-time production tracking is essential.

What are the typical day-to-day responsibilities of someone working in a Manufacturing Execution System (MES) role?

Professionals in an MES role are responsible for configuring, monitoring, and optimizing the software systems that track and control manufacturing processes on the production floor. Daily tasks often include troubleshooting system issues, analyzing production data to support decision-making, and collaborating closely with production, quality, and IT teams to ensure seamless workflow integration. They may also be involved in implementing new system features, maintaining system documentation, and training end-users on MES functionalities. This role requires a proactive approach to problem-solving and strong collaboration to ensure production efficiency and product quality.

What are the key skills and qualifications needed to thrive in the Manufacturing Execution System position, and why are they important?

To thrive in a Manufacturing Execution System (MES) role, you need a solid understanding of manufacturing processes, strong analytical skills, and often a degree in engineering, information technology, or a related field. Familiarity with MES platforms (such as Siemens Opcenter, Rockwell FactoryTalk, or GE Proficy), database management, and relevant certifications are commonly required. Effective communication, problem-solving, and project management abilities are crucial soft skills for success in this position. These competencies ensure seamless integration of technology on the production floor, enabling efficient operations and quick response to production challenges.

What are popular job titles related to Manufacturing Execution System jobs in Oregon? For Manufacturing Execution System jobs in Oregon, the most frequently searched job titles are:
What job categories do people searching Manufacturing Execution System jobs in Oregon look for? The top searched job categories for Manufacturing Execution System jobs in Oregon are:
Manufacturing Execution System jobs near you
Director, Quality Engineering & Computer System Assurance

Director, Quality Engineering & Computer System Assurance

Seran BioScience

Bend, OR

Full-time

PTO

Posted 15 days ago

Job description

Seran BioScience seeks a Director, Quality Engineering & Computer System Assurance (CSA) to oversee and provide strategic and operational leadership for the organization's validation, qualification, and computerized systems assurance programs.  This role will support GMP manufacturing, laboratory, and quality systems that stretch across clinical and commercial operations.
 
This position is responsible for establishing and maintaining a risk-based validation and CSA framework ensuring that facilities, utilities, equipment, analytical methods, processes, and computerized systems remain in a validated state throughout their lifecycle. The Director, Quality Engineering & CSA ensures all validation and data integrity activities comply with FDA, EU, and international regulatory requirements, including cGMP, GAMP guidance, and current regulatory expectations for data integrity.
 
The role partners with Engineering, Manufacturing, Quality Control, IT, Regulatory Affairs, and Technical Operations to ensure validated systems and processes enable safe, compliant, and reliable manufacturing of clinical and commercial products. The Director, Quality Engineering & CSA also serves as a key Quality leader during regulatory inspections, client audits, and internal quality reviews, and drives continuous improvement initiatives related to validation lifecycle management, computerized system assurance, and data governance.
Duties and Responsibilities
Strategic Leadership
  • Develops and implements the site strategy for Quality Engineering and Computer System Assurance(CSA) programs
  • Supports the establishment governance structures for risk-based validation lifecycle management including planning, execution, maintenance, and periodic review
  • Leads initiatives to modernize validation practices including CSA adoption, digital validation approaches, and automation lifecycle management
  • Defines key performance indicators (KPIs) and metrics to measure effectiveness of QualityEngineering and CSA programs
  • Provides leadership to cross-functional teams supporting validation, qualification, and system lifecycle activitie
Validation Lifecycle Oversight
  • Provides Quality leadership and oversight of validation programs including:
    • Facility, utility, and equipment qualification, Cleaning validation, Computerized systems validation / assurance, & Manufacturing automation systems
Key activities include:
  • Approval and oversight of validation lifecycle documentation including: 
    • Validation Master Plans (VMP), User Requirement Specifications (URS), Functional and Design Specifications, Risk assessments, IQ/OQ/PQ protocols and reports, & Validation summary reports
  • Ensures validation activities comply with internal procedures and regulatory requirements and remain aligned with the site Validation Master Plan
  • Provides quality oversight for commissioning, qualification, and validation activities in highly automated manufacturing environments
  • Ensures validated systems maintain a continuous state of control throughout their operational lifecycle
Computer System Assurance (CSA) & Data Integrity
  • Supports the design and implementation of the organization's Computer System Assurance (CSA) and Computerized System Validation (CSV) programs
  • Ensures computerized systems comply with data integrity principles (ALCOA++) and regulatory expectations
  • Oversees validation lifecycle management for computerized systems including:
    • Manufacturing Execution Systems (MES), Laboratory Information Management Systems (LIMS), Quality management systems, Electronic Batch Record Systems, & Enterprise resource planning systems
  • Implements risk-based testing approaches consistent with GAMP 5 and modern CSA methodologies
  • Leads initiatives to strengthen enterprise data integrity governance programs across manufacturing, laboratory, and quality systems
  • Supports system lifecycle activities including system upgrades, migrations, and decommissioning
Operational Quality Engineering Support
  • Provides QA oversight and approval for quality system elements impacting validated systems including:
    • Change control processes impacting validated systems and processes, Deviation and investigation management, Corrective and Preventive Actions (CAPA), Risk management and impact assessments, & Periodic reviews of validated systems
  • Ensures that validation and CSA programs remain aligned with corporate policies, regulatory guidance, and evolving industry standards
  • Provides QA support for technology transfer, new product introductions, and site capital projects
  • Serves as the Quality Engineering representative for site project teams implementing new equipment, systems, or manufacturing technologies
  • Supports troubleshooting of complex process or system issues impacting validated systems
  • Serve as subject matter expert for validation, computerized systems assurance, and data integrity during regulatory inspections and Client audits
  • Leads preparation and inspection readiness programs related to validation and data integrity
Leadership & People Management
  • Leads and develops a high-performing Quality Engineering and CSA organization
  • Provides mentoring, coaching, and professional development for technical staff
  • Establish clear departmental goals aligned with organizational quality and operational objectives
  • Conducts performance reviews and ensure staff maintain appropriate training and GMP qualifications
  • Fosters a culture of quality ownership, compliance, and continuous improvement
Required Knowledge and Skills
  • Broad knowledge of FDA and international regulations related to GMPs and Pharmaceuticals
  • Experience organizing and managing work responsibilities while working independently with minimal oversight
  • Deep expertise in Computer System Validation / Computer System Assurance
  • Validation lifecycle management, Data integrity regulations and industry guidance, Risk-based validation methodologies
  • Time and project management skills with the ability to multi-task and meet deadlines
  • Excellent verbal and written communication skills
  • Excellent interpersonal and customer service skills
  • Excellent organizational skills and attention to detail
  • Strong analytical and problem-solving skills
  • Strong supervisory and leadership skills
  • Ability to prioritize tasks and to delegate them when appropriate
  • Willingness to accept feedback from a variety of sources
  • Ability to constructively manage conflict
  • Ability to collaborate and work in cross-functional teams
  • Ability to function well in a high-paced and at times stressful environment
  • Ability to maintain productive relationships with coworkers, clients, and other contacts outside the company
  • Proficient with Microsoft Office Suite or related software
Education and Experience
  • Bachelor's degree, preferably in a scientific discipline. Preference will be given to those with an advanced degree 
  • Minimum of 10+ years previous GMP and Quality experience in the Pharmaceutical or Biotechnology industry
  • Minimum of 5+ years previous experience with qualification/validation/CSA activities in a QA or Technical capacity
  • Demonstrated experience with regulatory inspections by the FDA and EU authorities
Physical Requirements
  • Prolonged periods of sitting or standing at a desk and working on a computer
  • Must be able to lift up to 15 pounds at times
  • Adheres to consistent and predictable in-person attendance 
Visit https://www.seranbio.com/careers to learn more about company culture and the community of Bend, Oregon.
 
Applicants must be authorized to work for an employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
 
Benefits Summary:
Seran employees accrue over four weeks of paid time off annually. Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period. Various health plans allow employees to find the best coverage for their individual or family needs with minimal employee contributions. Seran covers each employee with basic life and long-term disability, giving access to increase or add coverage. An Employee Assistance Program provides support for all things related to our employees' wellbeing, along with access to pet insurance.
 
The Corporate Headquarters of Seran BioScience are located at 63047 Layton Ave, Bend, OR 97701
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
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