Change control processes impacting validated systems and processes, Deviation and investigation ... Serves as the Quality Engineering representative for site project teams implementing new equipment ...
Change control processes impacting validated systems and processes, Deviation and investigation ... Serves as the Quality Engineering representative for site project teams implementing new equipment ...
Engineering Optimization & Process Development * Create pile matrices for purchase orders across active SOLV projects using thePropttool with guidance from senior engineers. * Follow standardized ...
New
Engineering Optimization & Process Development * Create pile matrices for purchase orders across active SOLV projects using thePropttool with guidance from senior engineers. * Follow standardized ...
New
A minimum of 1+ years' experience in the construction/engineering industry. * Skilled in organizing ... Comprehensive knowledge of construction materials, methods, and building processes. * Working ...
A minimum of 1+ years' experience in the construction/engineering industry. * Skilled in organizing ... Comprehensive knowledge of construction materials, methods, and building processes. * Working ...
ESI Controls Engineer
Sisters, OR · On-site
$120K - $150K/yr
Industrial Process Automation. * Bachelor's degree in Engineering or a similar technical field from an accredited university. * Working knowledge of ISA, NFPA, UL, safety codes, fire codes, and other ...
Quick apply
ESI Controls Engineer
Sisters, OR · On-site
$120K - $150K/yr
Industrial Process Automation. * Bachelor's degree in Engineering or a similar technical field from an accredited university. * Working knowledge of ISA, NFPA, UL, safety codes, fire codes, and other ...
ESI Controls Engineer
Sisters, OR · On-site
$120K - $150K/yr
Industrial Process Automation. * Bachelor's degree in Engineering or a similar technical field from an accredited university. * Working knowledge of ISA, NFPA, UL, safety codes, fire codes, and other ...
Quick apply
ESI Controls Engineer
Sisters, OR · On-site
$120K - $150K/yr
Industrial Process Automation. * Bachelor's degree in Engineering or a similar technical field from an accredited university. * Working knowledge of ISA, NFPA, UL, safety codes, fire codes, and other ...
CNC Programmer
Redmond, OR · On-site
$28 - $38.50/hr
Set up and operate CNC equipment for machining processes including milling, drilling, grinding, and turning. * Interpret engineering drawings, blueprints, and technical specifications to determine ...
CNC Programmer
Redmond, OR · On-site
$28 - $38.50/hr
Set up and operate CNC equipment for machining processes including milling, drilling, grinding, and turning. * Interpret engineering drawings, blueprints, and technical specifications to determine ...
Manufacturing Engineer II
Bend, OR · On-site
$95K - $105K/yr
Solid understanding of manufacturing processes and engineering principles * Knowledge of lean manufacturing, Six Sigma, and continuous improvement methods * Bachelor's degree in Engineering or ...
Manufacturing Engineer II
Bend, OR · On-site
$95K - $105K/yr
Solid understanding of manufacturing processes and engineering principles * Knowledge of lean manufacturing, Six Sigma, and continuous improvement methods * Bachelor's degree in Engineering or ...
Manufacturing Engineer II
Bend, OR · On-site
$95K - $105K/yr
Solid understanding of manufacturing processes and engineering principles * Knowledge of lean manufacturing, Six Sigma, and continuous improvement methods * Bachelor's degree in Engineering or ...
Manufacturing Engineer II
Bend, OR · On-site
$95K - $105K/yr
Solid understanding of manufacturing processes and engineering principles * Knowledge of lean manufacturing, Six Sigma, and continuous improvement methods * Bachelor's degree in Engineering or ...
Manufacturing Engineer II
Bend, OR · On-site
$95K - $105K/yr
Solid understanding of manufacturing processes and engineering principles * Knowledge of lean manufacturing, Six Sigma, and continuous improvement methods * Bachelor's degree in Engineering or ...
Quick apply
Manufacturing Engineer II
Bend, OR · On-site
$95K - $105K/yr
Solid understanding of manufacturing processes and engineering principles * Knowledge of lean manufacturing, Six Sigma, and continuous improvement methods * Bachelor's degree in Engineering or ...
This high-level engineering position requires an advanced foundation in mechanical engineering, with a focus on design for manufacturing processes, cross-functional collaboration, and innovation.
This high-level engineering position requires an advanced foundation in mechanical engineering, with a focus on design for manufacturing processes, cross-functional collaboration, and innovation.
Construction Inspector
Bend, OR · On-site
A minimum of 1+ years' experience in the construction/engineering industry. * Skilled in organizing ... Comprehensive knowledge of construction materials, methods, and building processes. * Working ...
Construction Inspector
Bend, OR · On-site
A minimum of 1+ years' experience in the construction/engineering industry. * Skilled in organizing ... Comprehensive knowledge of construction materials, methods, and building processes. * Working ...
Sales Engineer
Redmond, OR · On-site
Work closely with applications, production, and engineering teams to ensure alignment with manufacturing capabilities. * Provide actionable customer feedback to improve processes and offerings.
Sales Engineer
Redmond, OR · On-site
Work closely with applications, production, and engineering teams to ensure alignment with manufacturing capabilities. * Provide actionable customer feedback to improve processes and offerings.
Sales Engineer
Redmond, OR · On-site
Work closely with applications, production, and engineering teams to ensure alignment with manufacturing capabilities. * Provide actionable customer feedback to improve processes and offerings.
Sales Engineer
Redmond, OR · On-site
Work closely with applications, production, and engineering teams to ensure alignment with manufacturing capabilities. * Provide actionable customer feedback to improve processes and offerings.
Sales Engineer
Redmond, OR · On-site
Work closely with applications, production, and engineering teams to ensure alignment with manufacturing capabilities. * Provide actionable customer feedback to improve processes and offerings.
Quick apply
Sales Engineer
Redmond, OR · On-site
Work closely with applications, production, and engineering teams to ensure alignment with manufacturing capabilities. * Provide actionable customer feedback to improve processes and offerings.
Product Engineer
Redmond, OR · On-site
This mid-level engineering position requires a good foundation in mechanical engineering, with a focus on design for manufacturing processes, cross-functional collaboration, and innovation. This role ...
Product Engineer
Redmond, OR · On-site
This mid-level engineering position requires a good foundation in mechanical engineering, with a focus on design for manufacturing processes, cross-functional collaboration, and innovation. This role ...
This mid-level engineering position requires a good foundation in mechanical engineering, with a focus on design for manufacturing processes, cross-functional collaboration, and innovation. This role ...
This mid-level engineering position requires a good foundation in mechanical engineering, with a focus on design for manufacturing processes, cross-functional collaboration, and innovation. This role ...
Product Development Engineer
Bend, OR · On-site
... processes that enable the commercialization of unique and emerging technologies in new product categories. Qualifications * A Bachelor's Degree in Engineering. * Three to five years of experience in ...
Product Development Engineer
Bend, OR · On-site
... processes that enable the commercialization of unique and emerging technologies in new product categories. Qualifications * A Bachelor's Degree in Engineering. * Three to five years of experience in ...
Manufacturing Engineer
$77K - $99K/yr
You'll work at the intersection of Engineering and Production, owning key elements of configuration management, supporting new and existing processes, and driving continuous improvement across ...
Manufacturing Engineer
$77K - $99K/yr
You'll work at the intersection of Engineering and Production, owning key elements of configuration management, supporting new and existing processes, and driving continuous improvement across ...
Manufacturing Engineer
Bend, OR · On-site
$77K - $99K/yr
You'll work at the intersection of Engineering and Production, owning key elements of configuration management, supporting new and existing processes, and driving continuous improvement across ...
Manufacturing Engineer
Bend, OR · On-site
$77K - $99K/yr
You'll work at the intersection of Engineering and Production, owning key elements of configuration management, supporting new and existing processes, and driving continuous improvement across ...
... processes that enable the commercialization of unique and emerging technologies in new product categories. Qualifications * A Bachelor's Degree in Engineering. * Three to five years of experience in ...
... processes that enable the commercialization of unique and emerging technologies in new product categories. Qualifications * A Bachelor's Degree in Engineering. * Three to five years of experience in ...
Process Engineering information
See Bend, OR salary details
$52.2K - $61.1K
2% of jobs
$61.1K - $70.1K
9% of jobs
$78.2K is the 25th percentile. Wages below this are outliers.
$70.1K - $79K
15% of jobs
$79K - $87.9K
18% of jobs
The median wage is $91K / yr.
$87.9K - $96.8K
17% of jobs
$96.8K - $105.7K
14% of jobs
$106K is the 75th percentile. Wages above this are outliers.
$105.7K - $114.7K
11% of jobs
$114.7K - $123.6K
6% of jobs
$123.6K - $132.5K
4% of jobs
$132.5K - $141.4K
3% of jobs
$141.4K - $150.3K
1% of jobs
$52.2K
$97.1K
$150.3K
How much do process engineering jobs pay per year?
Are process engineers in demand?
What is process engineering?
What is the difference between Process Engineering vs Chemical Engineering?
| Aspect | Process Engineering | Chemical Engineering |
|---|---|---|
| Required Credentials | Bachelor's in Chemical, Mechanical, or Industrial Engineering; often certifications like Six Sigma | Bachelor's or higher in Chemical Engineering; professional engineer (PE) license may be preferred |
| Work Environment | Manufacturing plants, process facilities, industrial settings | Research labs, chemical plants, design offices |
| Industry Usage | Focuses on optimizing manufacturing processes and production efficiency | Designs chemical processes, develops new chemicals, and research |
Process Engineering primarily concentrates on improving and maintaining manufacturing processes within industrial settings, while Chemical Engineering involves designing chemical processes and developing new chemical products. Both roles require similar educational backgrounds and often overlap in industry applications, but their core focus areas differ.
What jobs do process engineers do?
What are some common challenges faced by process engineers when implementing process improvements in a manufacturing environment?
What are the key skills and qualifications needed to thrive as a process engineer, and why are they important?

Full-time
PTO
Re-posted 22 days ago
Job description
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:
Serán 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. Serán 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 Serán 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.
About Seran BioScience
Sourced by ZipRecruiter
Industry
Manufacturing
Company size
1 - 10 Employees
Headquarters location
Bend, OR, US
Year founded
2016