Title: Process Development Scientist (Regulated Industry)

Location: East of Puerto Rico (Open for Residents of Puerto Rico)

Contract Period: Approximately Six Months (Contract with ProQuality Network)

Work Schedule: 100% Onsite, Administrative Shift

Summary

Our client, a leading organization in the regulated biopharmaceutical industry, is seeking a Process Development Scientist to support process improvement, optimization, and troubleshooting activities. The selected professional will design, implement, and execute scientific experiments under minimal supervision to ensure operational excellence and compliance with cGMP standards. This role contributes directly to the success of development and production goals through technical expertise and collaboration with cross-functional teams.

Preferred Qualifications

• Provide direct support for inspection and packaging process requirements, design, and characterization.
• Develop process optimization strategies and troubleshoot operational issues in manufacturing operations.
• Apply advanced engineering principles to system, equipment, or process modifications and experiments.
• Analyze, interpret, and present results and recommendations for operational or engineering improvements.

Requirements

Technical Support & Equipment Knowledge

• Provide advanced technical support to AML-1 automatic packaging equipment and related processes.
• Strong knowledge of Vision System technologies and inspection/packaging concepts.
• Familiarity with process flow, layouts, and packaging SOPs, including serialization solution details.

Troubleshooting & Continuous Improvement

• Support investigations and root cause analyses for packaging and inspection process deviations.
• Identify and implement cost-reduction initiatives while maintaining product quality and compliance.

Process Characterization & Validation

• Develop and execute process characterization strategies.
• Establish and document testing strategies, protocols, and validation reports.
• Support SAT executions, challenge validations, and document generation.
• Participate in risk assessments and QRAES activities.

Project Coordination

• Coordinate project execution activities including material requests, training, production windows, and work order generation.

General Skills

• Excellent oral and written technical documentation abilities.
• Proficiency in MS Word, Excel, PowerPoint, Visio, PDF, and MS Project.
• Understanding of project management principles (timelines, schedules, predecessors).
• Flexibility to support multiple shifts or extended hours (up to 12 hours).
• Strong interpersonal and collaboration skills with cross-functional teams and OEMs.
• Self-driven and highly organized professional with attention to deadlines.

Key Functions

• Design, execute, and interpret scientific experiments and process development strategies.
• Ensure studies are conducted per approved protocols and applicable regulatory guidelines.
• Provide robust and reliable data supporting new or improved processes.
• Conduct data analysis, interpret findings, and communicate results effectively.
• Stay current with industry trends, literature, and technologies relevant to the role.
• Author scientific reports, technical summaries, and regulatory documentation.
• Collaborate across departments and external partners to achieve project milestones.
• Participate in safety, quality, and improvement initiatives within the department.

Education

• Doctorate (Ph.D.) OR
• Master’s Degree + 2 years of relevant scientific experience OR
• Bachelor’s Degree + 4 years of scientific experience.

Competencies and Skills

• Advanced scientific analysis and troubleshooting expertise.
• Strong laboratory and technical execution skills.
• Excellent verbal and written communication, including technical writing and reporting.
• Demonstrated skills in project management, analytical problem-solving, and conflict resolution.
• Highly organized, adaptable, and capable of managing multiple projects.
• Proficient in Microsoft Office tools (Word, Excel, PowerPoint).
• Strong knowledge of cGMP and regulatory compliance.
• Fully bilingual in English and Spanish.

Interested candidates are encouraged to apply through the job description link with an updated resume for evaluation.