Specialist - Manufacturing

BioPharma Consulting JAD Group

1d

About The Position

With minimal supervision, supports the execution of manufacturing and quality systems such as non‑conformances, process validation, procedures, training, and new product introductions. Applies process, operational, and scientific expertise, basic compliance knowledge, and analytical/troubleshooting skills to support manufacturing operations. May serve as primary production process owner for process support systems and assist with process ownership responsibilities for more complex process systems.

Requirements

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

Nice To Haves

• Bachelor’s degree in engineering is a plus.
• Deviations management experience.
• Deviation assessments.
• Experience with TrackWise.
• Biotech and manufacturing experience.

Responsibilities

• Initiate, revise, and approve manufacturing procedures; ensure all procedures reflect current operations. Serve as document owner.
• Assess process performance through floor observation and review of performance data; evaluate, plan, and implement solutions for process improvement opportunities.
• Provide troubleshooting support.
• Assist in generating training materials and may support training on scientific or technical aspects of the process.
• Support establishment of process monitoring parameters and control limits.
• Collect process‑monitoring data and support deviation assessments.
• Support timely execution of quarterly process monitoring reports.
• Ensure all non‑conformances are triaged within established goals. Author investigation reports. Execute corrective actions. Manage NC/CAPA closure within established timelines.
• Monitor and communicate incident trends. Review equipment/system Root Cause Analysis investigations and support trend evaluations.
• Assist in generating process validation protocols and reports. Support execution of process validation activities. Support collection and analysis of process validation data.
• May participate in regulatory inspections, New Product Introductions (NPI), and process or equipment modifications.
• Participate in NPI assessments for documentation, materials, training, and equipment modification requirements.
• Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects.
• Assist manufacturing change owners with CCRB packages impacting the process.
• Participate in the assessment or implementation of special projects or initiatives.
• Other functions may be assigned.

Benefits

• 6-month contract with possible extension

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed