Specialist Manufacturing 35529

Inteldot; Juncos (PR); On-site; USD 80,000 - 120,000; Full time

Job summary

Inteldot is seeking an Administrative Shift professional to support manufacturing and quality systems in a biotech environment. The role involves deviations handling, procedure ownership, and process optimization under minimal supervision.

Responsibilities include contributing to CAPA, training material development, and regulatory inspection support to ensure compliant operations across Puerto Rico and the broader site network.

Qualifications

• Deviations management and assessment experience in biopharma or biotech manufacturing.
• Familiarity with TrackWise or equivalent quality systems.
• Experience supporting regulatory inspections and CAPA processes.

Responsibilities

• Initiate, revise, and approve manufacturing procedures and serve as document owner.
• Assess process performance and implement improvements based on data.
• Provide troubleshooting support for manufacturing operations.
• Assist in training materials and training on technical processes.
• Support process monitoring, data collection, and quarterly reports.
• Contribute to NC/CAPA investigations and closure within goals.
• Review investigations and support trend evaluations for equipment/processes.
• Assist with process validation protocols, reports, and data.

Skills

Deviations management

Deviation assessments

TrackWise

Biotech and manufacturing experience

Education

Doctorate

Master's + 2 years of Manufacturing Operations experience

Bachelor's + 4 years of Manufacturing Operations experience

Associate + 8 years of Manufacturing Operations experience

High school/GED + 10 years of Manufacturing Operations 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.

Administrative Shift (availability to work overtime may be required based on business demand)

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:

• Deviations management
• Deviation assessments
• Track wise
• Biotech and manufacturing experience

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 + 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