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Added 2 mins ago
Revit/BIM/Stratus Engineer
Tutor Perini
Mt. Vernon, NY
WDF Inc ., a Tutor Perini Company, is seeking a Revit/BIM/Stratus Engineer for our Mount Vernon, NY office as well as NY Metro area project sites.
Added 5 mins ago
Data Engineer
Deloitte
New York, NY · Jericho, NY · Rochester, NY
Are you an experienced, passionate pioneer in technology who wants to work in a collaborative environment? As an experienced Data Engineer you will have the ability to share new ideas and…
Added 44 mins ago
Data Architecture & Data Engineering Leader
Jobgether
Remote, United States
…steps. Our partner is looking for a Data Architecture & Data Engineering Leader based in the United…
Added 55 mins ago
PT
Product Support Engineer I 37764070
PDS Tech Commercial
Englewood, CO
- $31.97 USD / hour
PDS Tech Commercial is partnering with a leading organization in the aviation industry to hire a Product Support Engineer in Englewood, CO . If you're an aspiring engineer with a passion…
Added 55 mins ago
A/AI Machine Learning Engineering - E2
Lockheed Martin
Littleton, CO
…intelligence algorithms for mission systems, supporting the technology development life cycle from requirements generation through development, integration, and testing, as well as research…
Added 56 mins ago
A/AI Machine Learning Engineering - E2
Lockheed Martin
Littleton, CO
…intelligence algorithms for mission systems, supporting the technology development life cycle from requirements generation through development, integration, and testing, as well as research…
Added 1 hour ago
Lead, Senior or Expert Test & Evaluation Engineer - PAC-3
The Boeing Company
Huntsville, AL
The Integrated Air and Missile Defense (IAMD) Systems Engineering, Integration and Test (SEIT) organization is seeking a Lead, Senior or Expert Test & Evaluation Engineer to serve as the…
Added 1 hour ago
Lead or Senior Responsible Engineer - PAC-3 Seeker IPT
The Boeing Company
Huntsville, AL
…missiles, and advanced aircraft where Boeing is the original engineering manufacturer of the seeker. Boeing’s seekers provide active data to the PAC-3 missile which enables it to acquire,…
Added 1 hour ago
Senior Systems Engineer - IFPC-2
The Boeing Company
Huntsville, AL
Bachelor of Science degree in Engineering, Engineering Technology (including Manufacturing Technology), Computer Science, Data Science, Mathematics, Physics, Chemistry or non-US equivalent…
Added 2 hours ago
J
Practice Director, Data & AI
Jobgether
Remote, United States
- $200,000 to $230,000 USD / year
Lead data modernization initiatives: Oversee offerings covering data strategy, architecture, integration, engineering, governance, quality, literacy, lineage, cloud data platforms,…
Added 2 hours ago
Principal Software Engineer
Robert Half
Knoxville, TN
Robert Half is hiring! We are looking for a Principal Software Engineer to lead the design and delivery of modern AI-driven software solutions. This role combines hands-on engineering with…
Added 2 hours ago
SA
Senior Applications Engineer, Maritime Autonomy (R6378)
Shield AI
United States
- $130,000 to $200,000 USD / year
…technical expertise during deployment, and ensure successful integration of our AI and autonomy products. You’ll also collaborate internally with engineering teams, with opportunities to…
Added 4 hours ago
PI
Process Equipment Engineer
Pfizer Inc
CT
- $99,200 to $165,400 USD / year
We are seeking a Process Equipment Engineer to join the CRD Manufacturing team in Groton, CT. The Process Equipment Engineer will be involved in the design, development and deployment of…
Added 5 hours ago
Storage Engineer – Enterprise Data Center & Cloud Services
GD Information Technology, Inc.
United States
GDIT is seeking a Storage Engineer for the Federal Civilian Division to join our outstanding team! You will support a large‑scale, global Cloud and Data Center Services program for the U.S.…
Added 5 hours ago
Power Automation Developer
GD Information Technology, Inc.
Remote, United States
…with a strong focus on secure application architecture, system integration, and custom development. This role blends architectural leadership with active solution delivery and requires…
Added 7 hours ago
Solution Architecture
Colgate-Palmolive Company
Piscataway, NJ
We are excited to invite applications to join the Professional Engagement group within our Global Information Technology Organization (GIT) as a Solution Architect. You will join an agile…
Added 8 hours ago
Project Travel Coordinator
Deloitte
Honolulu, HI
Our Deloitte AI & Engineering team to transform technology platforms, drive innovation, and help make a significant impact on our clients' success. You'll work alongside talented…
Added 8 hours ago
South Asia Policy and Engagement Support Specialist
Deloitte
Honolulu, HI
Our Deloitte AI & Engineering team to transform technology platforms, drive innovation, and help make a significant impact on our clients' success. You'll work alongside talented…
Added 8 hours ago
Counter-Unmanned Systems (C-UxS) Operational Planner
Deloitte
Honolulu, HI
Our Deloitte AI & Engineering team to transform technology platforms, drive innovation, and help make a significant impact on our clients' success. You'll work alongside talented…
Added 8 hours ago
Logistics Planning and Operations Support Specialist - Lead Integration Engineer II
Deloitte
Honolulu, HI
Our Deloitte AI & Engineering team to transform technology platforms, drive innovation, and help make a significant impact on our clients' success. You'll work alongside talented…
Added 8 hours ago
M
Network / System Engineer III
ManpowerGroup
Chandler, AZ
- $65 to $70 USD / hour
Our client, a leading financial services organization, is seeking a Network / System Engineer III to join their team. As a Network / System Engineer III, you will be part of the Consumer…
Added 8 hours ago
Data Engineer
Deloitte
Tempe, AZ
Are you an experienced, passionate pioneer in technology who wants to work in a collaborative environment? As an experienced Data Engineer you will have the ability to share new ideas and…
Added 8 hours ago
Artificial Intelligence (AI) Solutions Engineer/ Developer
Robert Half
Phoenix, AZ
Demonstrated experience working with AI and LLM technologies, including AI platforms, APIs, prompt engineering, and workflow integration.
Added 8 hours ago
Senior Staff Software Engineer - Agentic IT Operations
NVIDIA USA
CA
We are seeking a Senior Staff Software Engineer to define the technical strategy for autonomous AI-driven enterprise operations at NVIDIA. You will set the architecture that transforms IT…
Added 9 hours ago
SW Development Engineer 2
DexCom Inc
San Diego, CA
…Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing…

Barry-Wehmiller

Process Development Engineer - MSAT

Raleigh, NC, United States

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Job details

Experience: 5 to 10 years of experience in pharmaceutical or biotechnology GMP environment
Posting language: English
Posted: Oct 29, 2026

Original job description

About Us:

BW Design Group is a fully integrated architecture, engineering, construction, system integration, and consulting firm committed to helping our clients realize their most critical goals from Strategy to Commercialization. As the only firm born from a manufacturing technology company to become an independent and fully integrated firm, we combine deep domain expertise in the manufacturing environment with an approach that is built to serve the dynamic needs of our clients. Rooted in our distinct culture of Truly Human Leadership, we cultivate the leaders who will define tomorrow and partner with our clients in the food & beverage, life sciences, industrial, and advanced technology industries to build the future of manufacturing and technology.

Barry-Wehmiller is a diversified global supplier of engineering consulting and manufacturing technology for the packaging, corrugating, sheeting and paper-converting industries. By blending people-centric leadership with disciplined operational strategies and purpose-driven growth, Barry-Wehmiller has become a $3 billion organization with nearly 12,000 team members united by a common belief: to use the power of business to build a better world.

Job Description:

About Us:

Who You’ll Work With You will join one of our nearly 50 offices in the US, be part of a committed team of over 2000 professionals, and work in teams and directly with our clients doing work that is shaping the world around us. You will be welcomed into a rapidly growing business and team and empowered to make an impact. You will be valued, cared for, and challenged on your path to becoming a world-class professional consultant and surrounded by leaders who are committed to creating an environment that enables you to realize your own success and fulfillment.

When you join Design Group as a Process Development Engineer, you are joining a team that will challenge you and position you for growth. In this role, you will work with a team of industry experts to help the world’s leading companies solve their most difficult problems. You will join our Regulatory Compliance Practice and partner with seasoned leaders, technical specialists, and subject matter experts to deliver the highest quality solutions to our clients with consistency and accuracy.

Job Description:

This role supports biotechnology and pharmaceutical clients with robust equipment and process validation, technology transfer, troubleshooting, and manufacturing optimization. The ideal candidate demonstrates expertise across process, cleaning, and equipment validation domains, with a proven track record of leading complex projects and cross-functional teams in GMP environments. We seek someone with strong analytical and problem-solving capabilities to rapidly assess complex manufacturing challenges and drive operational excellence across diverse modalities.

Primary Responsibilities

Prepare validation or performance qualification protocols, specifications, and associated documentation for new or modified manufacturing processes, systems, or equipment
Conduct validation or qualification tests of new or existing processes, equipment, or software in accordance with internal protocols or external standards
Develop validation master plans, process flow diagrams, test cases, or standard operating procedures
Develop and document process understanding strategies aligned with ICH Q8 principles, including design space definition, parameter interaction mapping, and control strategy justification
Execute quality risk management activities compliant with ICH Q9, including failure mode and effects analysis (FMEA), risk assessment, risk control implementation, and risk communication
Establish and implement integrated control strategies combining unit operation controls, in-process controls, and end-product specifications as defined in ICH Q10
Lead investigations and perform troubleshooting following process deviations, trends, or issues, including designing and performing development studies at small- or full-scale to support technology transfer or investigations
Develop, troubleshoot, and implement improvements to processes that enhance safety, robustness, efficiency, and cost performance
Design and execute cleaning validation and optimization studies
Conduct root-cause analysis and drive corrective actions
Lead the transfer of drug substance processes to and from manufacturing facilities
Evaluate and optimize processes to improve efficiency and quality
Prepare, maintain, or review validation and compliance documentation
Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems
Partner with regulatory affairs to ensure validation strategies and control strategies meet current FDA expectations and ICH Q8/Q9/Q10 guidelines
Partner with cross-functional client teams including manufacturing operations, quality, process development, and regulatory affairs

Experience

B.S. or higher in a technical discipline related to pharmaceutical manufacturing (chemical engineering, biomedical engineering, pharmaceutical engineering, etc.)
5 to 10 years of experience in pharmaceutical or biotechnology GMP environment
Demonstrated expertise in process, cleaning, and equipment validation
Demonstrated knowledge of FDA regulatory requirements for process understanding and control, including ICH Q8 (Pharmaceutical Development), ICH Q9 (Quality Risk Management), and ICH Q10 (Pharmaceutical Quality System)
Track record of developing science-based control strategies and design spaces aligned with ICH Q8/Q9/Q10 principles
Track record of hands-on troubleshooting and rapid problem resolution in GMP environments
Proven ability to quickly understand complex manufacturing systems and identify optimization opportunities

Technical Skills

Understanding of GMP principles and FDA expectations for process validation and control strategy implementation
Mastery of ICH Q8 principles: process understanding, design space development, parameter interactions, and lifecycle approach to pharmaceutical quality
Proficiency in ICH Q9 Quality Risk Management methodologies including risk assessment, FMEA, and risk-based control strategy development
Capability to implement ICH Q10 pharmaceutical quality system principles including integrated control strategies, continual improvement, and knowledge management
Knowledge of FDA guidance documents on Process Validation (2011) and Process Understanding
Design of experiments (DOE) and statistical analysis
Data management and documentation systems
Scale-up and technology transfer
Upstream/downstream processing
Strong communication and ability to clearly explain technical concepts to diverse audiences, including regulatory rationale and scientific justification for process controls to regulatory inspectors and clients
Proven agility in learning new processes and equipment systems quickly
Ability to manage multiple client deliverables
Attention to detail with strong documentation discipline

Our culture and commitment to our people is what sets us apart. We foster an environment of mutual respect, integrity, and unconditional interest in the individual and collective success of our professionals. Our model and entrepreneurial mindset offer a rewarding, challenging, and highly flexible path.

As a Process Development Engineer, you will build a meaningful and fulfilling career with the support of professional development resources and mentorships including our First Year Experience program, Individual Development Plans, and Career Path resources and tools. You will be surrounded by exceptional talent who will support your development as both a world-class engineer and a highly effective leader.

At Barry-Wehmiller we recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job. If your experience is close to what you see listed here, please still consider applying. We know that our differences often can bring about innovation, excellence and meaningful work - therefore, people from all backgrounds are encouraged to apply to our positions. Please let us know if you require reasonable accommodations during the interview process.

Barry-Wehmiller is an equal opportunity employer. M/F/D/V This organization uses E-Verify.

Applicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments.

Company:

Design Group

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