Job Description

We are seeking a highly motivated Specialist Manufacturing to support manufacturing and quality operations in a GMP-regulated biopharmaceutical environment. The ideal candidate will provide technical and operational support for manufacturing systems, including non-conformances, process validation, process monitoring, training, procedural updates, and new product introductions (NPI). This role requires strong analytical, troubleshooting, technical writing, and cross-functional collaboration skills to ensure efficient and compliant manufacturing operations.

Key Responsibilities

• Initiate, revise, review, and approve manufacturing procedures to ensure alignment with current operations and compliance requirements.
• Serve as document owner for manufacturing procedures and related documentation.
• Assess process performance through floor observations and review of operational performance data.
• Identify, evaluate, and implement process improvement opportunities.
• Provide technical troubleshooting support for manufacturing operations and process systems.
• Assist in the development of technical and scientific training materials.
• Support and/or conduct technical training sessions for manufacturing personnel.
• Support the establishment of process monitoring parameters and control limits.
• Collect, analyze, and trend process monitoring data.
• Support the evaluation and investigation of process deviations.
• Assist with the preparation and timely execution of quarterly process monitoring reports.
• Ensure non-conformances are triaged within established timelines.
• Author and support investigation reports related to deviations and non-conformances.
• Execute corrective and preventive actions (CAPA) activities.
• Manage NC/CAPA records to ensure closure within established goals.
• Monitor, trend, and communicate manufacturing incidents and quality events.
• Review Root Cause Analysis (RCA) investigations and support trend analysis activities.
• Utilize root cause analysis tools such as 5 Why’s and causal factor analysis.
• Assist in the development of process validation protocols and reports.
• Support execution of process validation activities.
• Collect, analyze, and summarize process validation data.
• Support regulatory inspection readiness activities.
• Participate in audits and regulatory inspections as required.
• Ensure manufacturing activities comply with GMP and regulatory requirements.
• Participate in NPI activities and assess requirements for documentation, materials, training, and equipment modifications.
• Support process and equipment modification projects, including implementation activities and project coordination.
• Assist manufacturing change owners with CCRB packages and change control documentation impacting processes.
• Participate in special projects, process optimization initiatives, and continuous improvement activities.
• Support cross-functional teams to drive operational excellence and compliance initiatives.
• Track project actions, timelines, and deliverables to ensure successful completion.

Requirements

Required Skills & Competencies

• Strong technical understanding of bioprocessing unit operations.
• Experience working in GMP manufacturing environments.
• Experience handling deviations, investigations, and non-conformances.
• Knowledge of CAPA systems and Root Cause Analysis methodologies.
• Strong technical writing and report development skills.
• Experience with process validation and process monitoring activities.
• Understanding of regulatory compliance requirements and manufacturing quality systems.
• Ability to collaborate effectively with Manufacturing, Quality, Process Development, and Technical Operations teams.
• Strong organizational, analytical, and troubleshooting skills.
• Basic project management skills with the ability to track actions and meet deadlines.
• Basic knowledge of statistical process control and control charting.

Education & Experience

• Doctorate Degree; OR
• Master’s Degree with 2+ years of Manufacturing Operations experience; OR
• Bachelor’s Degree with 4+ years of Manufacturing Operations experience; OR
• Associate’s Degree with 8+ years of Manufacturing Operations experience; OR
• High School Diploma/GED with 10+ years of Manufacturing Operations experience.

Preferred Qualifications

• Experience supporting regulatory inspections and audit readiness activities.
• Experience with New Product Introductions (NPI).
• Familiarity with change control systems and CCRB processes.
• Ability to lead or participate in cross-functional initiatives and improvement projects.

Benefits

Work Schedule

• Administrative Schedule: Monday – Friday, 8:00 AM – 5:00 PM
• Overtime may be required based on business needs.
• Contract position