{"id":3479343,"url":"https://alion.io/job/barry-wehmiller-process-development-engineer-msat","title":"Process Development Engineer - MSAT","company":{"id":2191447,"name":"Barry-Wehmiller","domain":"barrywehmiller.com","url":"https://alion.io/company/barrywehmiller","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":76,"open_postings":61,"ghost_share":0,"stale_share":0.967,"repost_share":0,"time_to_fill_p50_days":42,"computed_at":"2026-11-01T06:10:25Z"}},"role":"Biotech","role_family":"Biotech","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Raleigh, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":110000,"max_usd":193000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":356},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Design of Experiments","optional":false},{"name":"FMEA","optional":false},{"name":"GMP","optional":false},{"name":"ICH Guidelines","optional":false}],"status":"live","first_seen_at":"2026-10-29T19:44:25Z","employer_posted_date":"2026-10-29","last_verified_at":"2026-11-01T17:14:58Z","board_verified":true,"closed_at":null,"days_open":3,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":3},"description":"About Us:\nBW 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:\nAbout Us:\nBW 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.\nBarry-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.\nWho You’ll Work With\nYou 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.\nWhen 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.\nJob Description:\nThis 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.\nPrimary Responsibilities\nPrepare validation or performance qualification protocols, specifications, and associated documentation for new or modified manufacturing processes, systems, or equipment\nConduct validation or qualification tests of new or existing processes, equipment, or software in accordance with internal protocols or external standards\nDevelop validation master plans, process flow diagrams, test cases, or standard operating procedures\nDevelop and document process understanding strategies aligned with ICH Q8 principles, including design space definition, parameter interaction mapping, and control strategy justification\nExecute quality risk management activities compliant with ICH Q9, including failure mode and effects analysis (FMEA), risk assessment, risk control implementation, and risk communication\nEstablish and implement integrated control strategies combining unit operation controls, in-process controls, and end-product specifications as defined in ICH Q10\nLead 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\nDevelop, troubleshoot, and implement improvements to processes that enhance safety, robustness, efficiency, and cost performance\nDesign and execute cleaning validation and optimization studies\nConduct root-cause analysis and drive corrective actions\nLead the transfer of drug substance processes to and from manufacturing facilities\nEvaluate and optimize processes to improve efficiency and quality\nPrepare, maintain, or review validation and compliance documentation\nAnalyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems\nPartner with regulatory affairs to ensure validation strategies and control strategies meet current FDA expectations and ICH Q8/Q9/Q10 guidelines\nPartner with cross-functional client teams including manufacturing operations, quality, process development, and regulatory affairs\nExperience\nB.S. or higher in a technical discipline related to pharmaceutical manufacturing (chemical engineering, biomedical engineering, pharmaceutical engineering, etc.)\n5 to 10 years of experience in pharmaceutical or biotechnology GMP environment\nDemonstrated expertise in process, cleaning, and equipment validation\nDemonstrated 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)\nTrack record of developing science-based control strategies and design spaces aligned with ICH Q8/Q9/Q10 principles\nTrack record of hands-on troubleshooting and rapid problem resolution in GMP environments\nProven ability to quickly understand complex manufacturing systems and identify optimization opportunities\nTechnical Skills\nUnderstanding of GMP principles and FDA expectations for process validation and control strategy implementation\nMastery of ICH Q8 principles: process understanding, design space development, parameter interactions, and lifecycle approach to pharmaceutical quality\nProficiency in ICH Q9 Quality Risk Management methodologies including risk assessment, FMEA, and risk-based control strategy development\nCapability to implement ICH Q10 pharmaceutical quality system principles including integrated control strategies, continual improvement, and knowledge management\nKnowledge of FDA guidance documents on Process Validation (2011) and Process Understanding\nDesign of experiments (DOE) and statistical analysis\nData management and documentation systems\nScale-up and technology transfer\nUpstream/downstream processing\nStrong 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\nProven agility in learning new processes and equipment systems quickly\nAbility to manage multiple client deliverables\nAttention to detail with strong documentation discipline\nOur 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.\nAs 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.\nAt 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.\nBarry-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:\nDesign Group","description_format":"text","description_chars":9751,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Professional development"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Industrial Machinery","Packaging & Labeling","Engineering Services"],"lifecycle":[{"event":"open","at":"2026-10-29T19:44:25Z"}],"visa":[],"liveness":{"score":63,"band":"ok","label":"Likely open","p_open":1,"p_active":0.632,"p_room":1,"age_days":2,"expected_fill_days":42,"reasons":["conf:4","stale_co","velocity","win:early","comp:brand"],"computed_at":"2026-11-01T06:10:25Z"},"pay":null,"html_url":"https://alion.io/job/barry-wehmiller-process-development-engineer-msat","json_url":"https://alion.io/job/barry-wehmiller-process-development-engineer-msat.json","meta":{"generated_at":"2026-11-01T23:22:34Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":35557,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-02T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":2191447},"rest":"https://alion.io/mcp/rest/get_company?id=2191447"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fbarry-wehmiller-process-development-engineer-msat"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fbarry-wehmiller-process-development-engineer-msat"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fbarry-wehmiller-process-development-engineer-msat"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/barry-wehmiller-process-development-engineer-msat\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fbarry-wehmiller-process-development-engineer-msat"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3479343}},{"tool":"search_jobs","arguments":{"company":"barrywehmiller.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3479343},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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