Specialist Manufacturing 35716

Inteldot; Juncos (PR); On-site; USD 65,000 - 85,000; Full time

Job summary

Inteldot seeks a Manufacturing Operations professional to support execution of quality and manufacturing systems in Puerto Rico. With minimal supervision, you will handle non-conformances, process validation, procedures, training, and new product introductions, applying process knowledge and analytical skills to sustain operations.

You will serve as document owner, assess process performance, provide troubleshooting, and help generate training materials.

Qualifications

• Requires strong manufacturing operations knowledge and ability to work with operators on the floor.
• Experience with document control: creating, reviewing and approving procedures and records.
• Knowledge of non-conformance handling, CAPA, process validation, and training materials.

Responsibilities

• Initiate, revise, and approve manufacturing procedures and reflect current operations.
• Assess process performance by observing floor operations and reviewing data for improvements.
• Provide troubleshooting support for process issues and deviations.
• Assist in generation of training materials and deliver training on process steps.
• Support establishment of monitoring parameters and control limits; collect monitoring data.
• Support timely execution of quarterly process-monitoring reports and CAPA closure.
• Assist with CCRB packages impacting processes and participate in NPI activities.

Skills

Manufacturing operations experience

Document management

Experience with manufacturing floor

Education

Doctorate in a relevant field

Master's degree in Manufacturing Operations

Bachelor's degree in related field with 4 years experience

Associate's degree with 8 years experience

High school / GED with 10 years experience

Job description

Inteldot has over 15 years in the life science industry with allocations a cross Puerto Rico, United Sates, Europe and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.

Non Standard Shift

Job Description

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.

Knowledge & Requirements

• Manufacturing Operation experience
• Document Management, create new documents, review and approval of documents.
• Experience working with manufacturing operators.

Responsibilities

• 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.
• 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.
• Provide support of timely execution of the process monitoring quarterly reports.Non-Conformance and CAPA
• Ensure that all non-conformances are triaged within the established goal.
• Responsible for authoring investigation reports, execution of corrective actions and managing NC/CAPA closure within established goal.
• Monitor and communicate incidents trends.
• Review equipment/system Root Cause Analysis investigations and support trend evaluations.
• Assist with generation of process validation protocols and reports and with the execution of the process validation.
• Support collection and analysis of process validation data.
• Participate in regulatory inspections, New Product Introductions, and Process or Equipment Modifications:
• Participate in the 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.
• Assist manufacturing change owner on CCRB packages impacting the process.
  

Education

• Doctorate OR Master's degree with 2 years of Manufacturing Operations experience, a Bachelor's degree with 4 years of Manufacturing Operations experience, an Associate's degree with 8 years of Manufacturing Operations experience, or a High school/GED with 10 years of Manufacturing Operations experience.