Specialist, Manufacturing - New Albany, OH

Military Spouse Corporate Career Network • New Albany, OH

1d • Onsite

About The Position

This role will support the execution of manufacturing/quality systems such as continuous improvement, technology transfer / new product introductions, process validation, manufacturing process/procedures, risk assessments, training, and non-conformance. They will apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support operations. You may also serve as the primary production process owner for process support systems and assist with process ownership responsibilities on process systems.

Requirements

• Doctorate degree Or Master’s degree and 2 years in Engineering, Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies.
• Or Bachelor’s degree and 4 years in Engineering, Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies.
• Or Associate’s degree and 8 years in Engineering, Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies.
• Or High school diploma / GED and 10 years in Engineering, Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies.

Nice To Haves

• Detailed technical understanding of bio-processing and manufacturing operations
• Develop, manage, and implement process improvements
• Experience with Lean principals (Kaizen, Six Sigma, Operational Excellence) and knowledge of problem-solving techniques
• Experience in participating and helping lead cross-functional teams
• Collaborate with staff at all levels in the organization, including technical and management staff within manufacturing, process development, and quality
• Experience with change control process and change management
• Skilled in performance of GMP production operations
• Regulatory knowledge and interactions
• Project management skills
• Excellent organizational, technical writing, presentation, and verbal skills
• Knowledge of data analysis and control charting

Responsibilities

• As a document owner, initiate, revise, and approve manufacturing procedures to ensure all procedures reflect current operations.
• Assess process performance by; observation of floor operations, review of performance data and provide troubleshooting support.
• Evaluate, plan, and implement solutions for process improvement opportunities.
• Assist in generation of training materials and / or in providing training on scientific or technical aspects of the process.
• Complete risk evaluations for new processes or changes to existing processes and issue the summary reports of these evaluations.
• Bring continuous improvement initiatives for cost reduction or cycle time reduction and participate in the assessment or implementation of such special projects or initiatives.
• Support process monitoring parameters and control limits based off critical metrics and recommend improvements.
• Collect process-monitoring data and support the assessment of deviations.
• Provide support of timely process monitoring quarterly reports.
• Participate in technology transfer / NPI process to assess requirements for documentation, materials, training, and equipment modifications.
• Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects.
• Ensure that all Non-conformance are triage within the established goal.
• Assist with investigations, corrective actions and NC/CAPA closure within established goal.
• Monitor and communicate incidents trends.
• Review equipment/system Root Cause Analysis investigations and support trend evaluations.
• Assist with the process validation and generation of process validation protocols and reports.
• Support collection and analysis of process validation data.
• May participate in regulatory inspections.
• As manufacturing change owner, provide assessments on CCRB records impacting the process.

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible.

What This Job Offers

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