Specialist Manufacturing

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

FUNCTIONS

• Initiate, revise, and approve manufacturing procedures; ensure procedures reflect current operations.
• Serve as document owner for assigned procedures.
• Assess process performance through floor observation and data review; identify and implement process improvement opportunities.
• Provide troubleshooting support for manufacturing operations.
• Assist in generating training materials and delivering technical/scientific 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 non‑conformances are triaged within established timelines.
• Author investigation reports and execute corrective actions.
• Manage NC/CAPA closure within required goals.
• Monitor and communicate incident trends.
• Review equipment/system RCA investigations and support trend evaluations.
• Assist in generating process validation protocols and reports.
• Support execution of process validation activities.
• Collect and analyze validation data.
• Participate in regulatory inspections, new product introductions, and process/equipment modifications.
• Assess documentation, materials, training, and equipment needs for NPI.
• Provide project management support for process or equipment modification projects.
• Assist manufacturing change owners with CCRB packages impacting the process.
• Participate in assessments and implementation of special projects or initiatives.
• Perform additional duties as assigned.

SKILLS

• Detailed technical understanding of bioprocessing unit operations.
• Skilled in GMP production operations.
• Knowledge of regulatory expectations and interactions.
• Ability to communicate and collaborate with manufacturing, process development, and quality teams.
• Strong organizational, technical writing, and presentation skills.
• Basic project management skills.
• Basic knowledge of control charting and process monitoring.

Requirements

EDUCATION & EXPERIENCE 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

Preferred Education:

• Background in Life Sciences, Biology, Chemistry, or Engineering.

PREFERRED QUALIFICATIONS

• Experience handling deviations, non‑conformances, and investigations.
• Strong technical writing and report development skills.
• Proficiency with RCA tools (5 Why’s, Fishbone, Causal Factors, Kepner‑Tregoe).
• Experience with bioprocessing unit operations and GMP environments.
• Familiarity with Lean Manufacturing and continuous improvement.
• Strong project management and action‑tracking skills.
• Proficiency in GDP and regulated documentation practices.
• Experience with systems/tools: TrackWise, VEEVA, MES, SmartSheet, Power BI, Spotfire, CDOCS, and process monitoring platforms.
• Excellent communication skills in English and Spanish.
• Team‑oriented, strong interpersonal skills, able to work under minimal supervision and high workload.
• Ability to work extended hours when required.

Benefits

• 6-month to 1 year contract- with possible extension
• Administrative Shift