Specialist Manufacturing 35221

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

1. Experience (manufacturing, process development, or quality assurance) in Biotech or pharmaceutical industry with progressively increasing responsibility and demonstrated experience in compliance, problem solving, critical thinking, project management, and quality systems.
2. Deviations documentation and Change Control Management.
3. Experience in leading multiple, contending priorities in a fast-paced environment with minimal direction.
4. Excellent communication skills, both written and verbal (including technical writing and presentation skills) in English, with ability to collaborate productively with technical and senior management staff.

• →Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.
• →Assess process performance by observation of floor operations and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities.
• →Support establishment of process monitoring parameters and control limits. Collect process-monitoring data and support the assessment of deviations.
• →Responsible for managing NC/CAPA closure within established goal.
• →Review equipment/system Root Cause Analysis investigations and support trend evaluations.
• →Assist with generation of process validation protocols and reports.
• →Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications.
• →Assist manufacturing change owner on CCRB packages impacting the process.

Doctorate or -Master’s + 2 years of Manufacturing Operations experience or Bachelors + 4 years of Manufacturing Operations experience or Associates + 8 years of Manufacturing Operations experience or High school/GED + 10 years of Manufacturing Operations experience