Manufacturing Specialist Process Engineer - New Albany OH
About The Position
The Specialist, Manufacturing supports the execution of manufacturing and quality systems, including continuous improvement, technology transfer and new product introductions, process validation, manufacturing processes and procedures, risk assessments, training, and non-conformance. The role applies process, operational, and scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support operations. The specialist may serve as the primary production process owner for process support systems and assist with process ownership responsibilities for process systems. The role maintains and improves manufacturing documentation and operations, supports process monitoring and investigations, and contributes to projects involving process or equipment changes. It also assists with validation activities, change control, corrective actions, and regulatory inspections as needed.
Requirements
- Doctorate degree; or master's degree and 2 years of experience in Engineering, Manufacturing, Packaging, or Quality at a pharmaceutical, medical device, or biotechnology company; or bachelor's degree and 4 years of such experience; or associate's degree and 8 years of such experience; or high school diploma/GED and 10 years of such experience.
Nice To Haves
- Detailed technical understanding of bioprocessing and manufacturing operations.
- Ability to develop, manage, and implement process improvements.
- Experience with Lean principles, including Kaizen, Six Sigma, and Operational Excellence, and knowledge of problem-solving techniques.
- Experience participating in and helping lead cross-functional teams.
- Ability to collaborate with technical and management staff at all levels, including in manufacturing, process development, and quality.
- Experience with change control processes and change management.
- Skill in performing GMP production operations.
- Regulatory knowledge and experience with regulatory interactions.
- Project-management skills.
- Excellent organizational, technical-writing, presentation, and verbal skills.
- Knowledge of data analysis and control charting.
Responsibilities
- Initiate, revise, and approve manufacturing procedures as a document owner to keep them aligned with current operations.
- Assess process performance by observing floor operations and reviewing performance data, and provide troubleshooting support.
- Evaluate, plan, and implement solutions for process improvement opportunities.
- Assist in creating training materials and/or providing training on scientific or technical aspects of the process.
- Complete risk evaluations for new processes or changes to existing processes and issue summary reports.
- Bring forward and participate in continuous improvement initiatives, including cost- or cycle-time-reduction projects.
- Support process monitoring parameters and control limits based on critical metrics, and recommend improvements.
- Collect process-monitoring data, support deviation assessments, and provide timely quarterly process-monitoring reports.
- Participate in technology transfer and new product introduction processes to assess documentation, materials, training, and equipment modification requirements.
- Assess, prioritize, justify, and provide implementation and project-management support for process or equipment modification projects.
- Ensure non-conformances are triaged within established goals.
- Assist with investigations, corrective actions, and non-conformance/CAPA closure within established goals.
- Monitor and communicate incident trends; review equipment/system root-cause-analysis investigations and support trend evaluations.
- Assist with process validation and generation of validation protocols and reports, and support collection and analysis of validation data.
- May participate in regulatory inspections.
- As a manufacturing change owner, provide assessments on CCRB records impacting the process.
Benefits
- Health and welfare plans for staff and eligible dependents.
- Retirement and Savings Plan with company contributions.
- Group medical, dental, and vision coverage.
- Life and disability insurance.
- Flexible spending accounts.
- Discretionary annual bonus program, or sales-based incentive plan for field sales representatives.
- Stock-based long-term incentives.
- Award-winning time-off plans.
- Career development opportunities.
- Flexible work models where possible.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
