Scientific Specialist – Validation & Inspection Systems

Job Summary

The Scientific Specialist is responsible for conceiving, designing, implementing, and executing scientific experiments and validation strategies that support the successful completion of project goals. Working under general supervision, this role contributes to process development, data integrity, and compliance within a regulated environment.

Key Responsibilities

• Design, execute, and evaluate experimental strategies to support project objectives.
• Interpret scientific data and assess its impact on ongoing projects and deliverables.
• Develop and implement new protocols and innovative approaches to address technical challenges.
• Ensure all studies and activities are conducted in compliance with approved protocols, regulatory requirements, and applicable guidelines.
• Provide input into new processes to ensure generation of robust, reliable, and high-quality data.
• Support validation and qualification activities, including documentation and execution.
• Contribute to vision inspection qualification and system characterization efforts.
• Monitor scientific and technological developments in the field and communicate relevant findings.
• Author scientific reports, technical summaries, and complex regulatory documentation.
• Collaborate cross-functionally with internal teams, suppliers, and external partners.
• Participate in project teams and may represent the department under guidance of senior staff.
• Provide technical guidance to peers in experimental design and data interpretation.
• Support departmental initiatives such as safety programs, recruiting, and committees.
• Develop timelines and ensure timely completion of assigned project deliverables.

Education

• Doctorate OR
• Master's + 2 years of Scientific experience OR

Qualifications & Experience

• -Bachelors + 4 years of Scientific experience.
• Experience in a regulated environment (pharmaceutical, biotech, or related industry).
• Proven ability to design experiments, analyze data, and interpret results.
• Strong technical writing skills for reports and regulatory documentation.
• Excellent communication and collaboration skills across multiple stakeholders.

Preferred Qualifications

• Proficiency in creating and executing validation and qualification documentation (CQV).
• Experience supporting vision inspection qualification and system characterization.
• Familiarity with automated vision inspection systems (highly desirable).
• Knowledge of Computer System Validation (CSV).
• Experience supporting CQV documentation and execution activities.
• Extensive experience in process development or manufacturing support within biotech, biopharma, or related industries.
• Strong ability to analyze and interpret complex process and experimental data to drive process understanding and optimization.
• Experience supporting process scale-up, technology transfer, and/or commercial manufacturing.
• Ability to integrate data from multiple sources (process, analytical, manufacturing) to develop actionable insights and recommendations.
• Strong track record of cross-functional collaboration (e.g., Manufacturing, Quality, Analytical, Regulatory).
• Experience working in a GMP-regulated environment, with deep understanding of data integrity and compliance requirements.
• Proficiency with scientific data analysis tools (e.g., JMP, Minitab, Excel or similar).
• Excellent technical communication skills, including writing reports, presenting data, and influencing stakeholders.

Additional Requirements

• Ability to work onsite.
• Availability to work flexible hours, including regular business hours, nights, and weekends, as required to meet project timelines.
• Strong organizational skills and ability to manage multiple priorities in a fast-paced environment.

Project Details

• Duration: 1.5 years
• Location: Onsite