Process Development Scientist

Under general guidance of a supervisor, the successful candidate will conceive, design, implement, and execute scientific experiments supporting process and equipment characterization, with a focus on packaging and vision systems. The role includes generating robust data, developing new protocols, supporting validation activities, and contributing to cross-functional project teams in a cGMP environment.

Responsibilities:

• Conceive, design, and execute scientific strategies for packaging processes and vision inspection systems.
• Lead or support process characterization including:
• Establishing testing strategies
• Designing and developing characterization protocols
• Authoring technical reports and risk assessments
• Executing validations (SAT, IOQ, PQ)
• Analyze data, interpret results, and assess the impact on project deliverables.
• Author scientific reports, regulatory documentation, and potentially invention disclosures or patents.
• Collaborate on cross-functional project teams and possibly mentor junior staff.
• Stay current with literature, technology trends, and regulatory requirements.
• Ensure compliance with internal protocols and external regulations/guidelines (e.g., cGMP, 21 CFR Part 11, GAMP).
• Support automation and packaging technology initiatives, including development and troubleshooting of vision systems.

Skills:

• Strong verbal and written communication skills
• Effective in cross-functional team environments
• Demonstrated leadership, initiative, and time/project management
• Excellent problem-solving and conflict-resolution capabilities
• High quality and compliance mindset suitable for regulated industries

Requirements

Education:

• Doctorate degree, OR
• Master’s degree and 5 years of scientific/engineering experience, OR
• Bachelor’s degree and 6 years of scientific/engineering experience
• Strong knowledge of cGMP practices and validation requirements
• Experience in process development, tech transfer, commissioning, and qualification
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)
• Fully bilingual in English and Spanish.

Preferred Qualifications:

• Vision system technologies: Cognex, Systech, Optel, Keyence, EISAI/BOSH/Syntegon, Seidenader, Brevetti, MvTech
• Analog/digital cameras, illumination systems, lenses, and frame grabbers
• Artificial Intelligence and Deep Learning
• PLC controls programming (Rockwell, Siemens, B&R)
• Programming languages: Visual Basic, .Net, C#, Python, JScript, VBScript
• Familiarity with SDLC methodologies, 21 CFR Part 11, and GAMP guidelines
• Automation process and/or Vision Inspection systems development

Benefits

• Administrative Shift
• 6-month contract with possible extension