Job Description

The Specialist Manufacturing supports the execution of manufacturing and quality systems with minimal supervision, including non‑conformances, process validation, procedures, training, and new product introductions. This role applies process, operational, and scientific expertise—along with compliance knowledge, analytical skills, and troubleshooting capabilities—to ensure robust, efficient, and compliant manufacturing operations. The Specialist may serve as a primary process owner for support systems and assist with ownership responsibilities for more complex process systems.

Key Responsibilities

• Initiate, revise, and approve manufacturing procedures; ensure procedures accurately reflect current operations.
• Serve as document owner for assigned procedures.
• Assess process performance through floor observation and review of performance data.
• Evaluate, plan, and implement solutions for process improvement opportunities.
• Provide troubleshooting support for manufacturing operations.
• Assist in generating training materials and support delivery of scientific or technical training.
• 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 timelines.
• Author investigation reports and execute corrective actions.
• Manage NC/CAPA closure within established goals.
• 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 validation data.
• Participate in regulatory inspections, New Product Introductions (NPI), and process/equipment modifications.
• Participate in NPI activities to assess documentation, materials, training, and equipment modification requirements.
• Assess, prioritize, justify, and support implementation of process or equipment modification projects.
• Assist manufacturing change owners with CCRB packages impacting the process.
• Participate in assessments or implementation of special projects or initiatives.
• Perform additional duties as assigned.

Skills

• Detailed technical understanding of bioprocessing unit operations.
• Skilled in GMP production operations.
• Regulatory knowledge and experience.
• Ability to participate in and help lead cross‑functional teams.
• Strong communication and collaboration skills across manufacturing, process development, and quality.
• Strong organizational, technical writing, and presentation skills.
• Basic project management skills.
• Basic knowledge of control charting.
• Ability to work independently and manage multiple priorities.

Requirements

Required Education

• 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

Preferred: Life Sciences, Biology, Chemistry, or Engineering.

Preferred Qualifications (Standout Attributes)

• Experience with bio‑processing unit operations.
• Knowledge of Root Cause Analysis methodologies (Fishbone, Six Boxes, 5 Why’s, Kepner‑Tregoe).
• Familiarity with Lean Manufacturing practices.
• Proficiency in GDP within regulated environments.
• Experience with systems/tools: TrackWise, VEEVA, MES, SmartSheet, Power BI, Spotfire, CDOCS, and process monitoring platforms.
• Ability to use AI tools such as data analytics and large language models.
• Strong technical writing and presentation abilities.
• Excellent written and verbal communication skills in English and Spanish.

Benefits

• 6-month contract with possible extension
• Administrative Shift