Manufacturing Operations Specialist
hace 1 mes
Mentor Technical Group is seeking a highly skilled Manufacturing Operations Specialist to join our team.
Job DescriptionThe ideal candidate will possess a strong understanding of bioprocessing unit operations and have experience in performing GMP production operations. They will be responsible for supporting the execution of manufacturing/quality systems, including non-conformances, process validation, procedures, training, and new product introductions.
This role involves applying technical expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. The selected individual may serve as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems.
Key Responsibilities:- Initiate, revise, and approve manufacturing procedures.
- Assess process performance by observation of floor operations and review of performance data.
- Provide troubleshooting support.
- Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.
- Support establishment of process monitoring parameters and control limits.
- Collect process-monitoring data and support the assessment of deviations.
- Ensure that all Non-conformances are triaged within the established goal.
- Responsible for authoring investigation reports.
- Responsible for execution of corrective actions.
- Responsible for managing NC/CAPA closure within established goal.
- Monitor and communicate incidents trends.
- Assist with generation of process validation protocols and reports.
- Support collection and analysis of process validation data.
To be successful in this role, you will need:
- A Doctorate degree, Master's degree with 3 years of experience, Bachelor's degree with 5 years of experience, Associate's degree with 10 years of experience, or High school diploma/GED with 12 years of experience in Manufacturing Operations.
- Detailed technical understanding of bioprocessing unit operations.
- Skilled in performance of GMP production operations.
- Regulatory knowledge and interactions.
- Ability to participate and lead cross-functional teams.
- Excellent communication and collaboration skills.
- Organizational, technical writing, and presentation skills.
- Basic project management skills.
- Basic knowledge of control charting.
The estimated salary range for this position is $70,000 - $100,000 per year, depending on qualifications and experience. Mentor Technical Group offers competitive benefits, including medical, dental, and vision insurance, 401(k) matching, and paid time off.
We are an equal opportunity employer and welcome applications from diverse candidates. If you are a motivated and experienced professional looking for a challenging role, please apply now
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