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.
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.
#LI-EPS
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
