Manufacturing Process Specialist (Quality & Operations Support) – Onsite | 6-Month Project

Position Summary

We are seeking a Manufacturing Process Specialist to support manufacturing and quality systems within a regulated environment. This role will contribute to the execution and continuous improvement of processes related to non-conformances, process validation, procedures, training, and new product introductions.

Working with minimal supervision, the selected candidate will apply scientific, operational, and analytical expertise to support manufacturing operations, ensure compliance, and drive process improvements. This role may also serve as a process owner for assigned systems and support more complex process ownership activities.

This is a 6-month onsite assignment, operating on an administrative shift, with overtime as required based on business needs.

Key Responsibilities

Process & Operational Support

• Author, revise, and approve manufacturing procedures, ensuring alignment with current operations.
• Serve as document owner for assigned procedures.
• Monitor and assess process performance through floor observations and data analysis.
• Identify improvement opportunities and implement effective solutions.
• Provide real-time troubleshooting support to manufacturing operations.
• Support the development of training materials and deliver technical training as needed.

Process Monitoring

• Support the definition and implementation of process monitoring parameters and control limits.
• Collect and analyze process monitoring data to identify trends and deviations.
• Contribute to the preparation and timely execution of periodic process monitoring reports.

Non-Conformance & CAPA Management

• Ensure timely triage and management of non-conformances in accordance with established timelines.
• Author and support investigation reports, including root cause analysis.
• Execute and track corrective and preventive actions (CAPAs).
• Monitor trends and communicate findings to relevant stakeholders.
• Support closure of NC/CAPA records within defined targets.

Process Validation

• Support the development of process validation protocols and reports.
• Assist in execution of validation activities.
• Collect, analyze, and interpret validation data to ensure process robustness.

Regulatory & Compliance

• Support regulatory inspection readiness and may participate in inspections as required.
• Ensure adherence to cGMP and applicable regulatory requirements.

New Product Introduction (NPI) & Change Management

• Participate in NPI activities, including assessment of documentation, materials, training, and equipment requirements.
• Support process and equipment modification projects, including planning and implementation.
• Assist with change control activities and CCRB packages impacting manufacturing processes.

Projects & Continuous Improvement

• Participate in cross-functional projects and site initiatives.
• Support implementation of operational excellence and continuous improvement efforts.
• Perform additional duties as assigned.

Qualifications

Education

• PhD in a relevant field OR
• Master’s degree + 2 years of Manufacturing Operations experience OR
• Bachelor’s degree + 4 years of Manufacturing Operations experience OR
• Associate degree + 8 years of experience OR
• High School Diploma/GED + 10 years of experience

Required Skills & Competencies

• Strong technical understanding of bioprocessing unit operations
• Hands-on experience in GMP manufacturing environments
• Knowledge of regulatory requirements and compliance practices
• Experience supporting deviations, investigations, and CAPA systems
• Strong analytical thinking and troubleshooting skills
• Ability to work effectively within cross-functional teams
• Strong communication and collaboration skills across technical and leadership levels
• Proficiency in technical writing and documentation
• Basic project management skills
• Familiarity with process monitoring tools, including control charting

Work Environment

• Location: Onsite
• Duration: 6-month project
• Schedule: Administrative shift
• Overtime: As required based on business needs

Why Join

This role offers the opportunity to contribute to high-impact manufacturing operations, supporting critical processes in a regulated environment while gaining exposure to process improvement, validation, and cross-functional collaboration.