Specialist Manufacturing 35466

Inteldot; Juncos (PR); On-site; USD 70,000 - 90,000; Full time

Job summary

Inteldot is seeking an individual for the Administrative Shift in Puerto Rico. This position involves supporting the execution of manufacturing and quality systems while ensuring compliance with GMP standards.

Candidates should have a strong background in biotechnology process support and experience in manufacturing operations. Key responsibilities include managing change controls, conducting deviation investigations, and leading training efforts. A competitive educational background with relevant experience is highly desired.

Qualifications

• Strong expertise in biotechnology pharmaceutical process support, particularly on Drug Substance processes.
• Knowledge in manufacturing operations systems and compliance.
• Ability to lead investigations and provide training.

Responsibilities

• Own change controls for manufacturing process changes.
• Support major/trend deviation investigations including Root Cause Analysis.
• Coordinate and support execution of functional tests and water tests.
• Assess process performance and implement process improvement solutions.

Skills

Biotechnology pharmaceutical process support

GMP pharmaceutical manufacturing systems

SAP

TrackWise

Electronic batch records (PAS/X)

Documents management systems (Veeva)

Education

Masters + 2 years of Manufacturing Operations experience

Bachelors + 4 years of Manufacturing Operations experience

Associates + 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

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.

Requirements

1. Experience in biotechnology pharmaceutical process support, especially on Drug Substance processes, and GMP pharmaceutical manufacturing systems.
2. Knowledge in SAP, TrackWise, electronic batch records (PAS/X), and documents management systems (Veeva).

Responsibilities

• Own change controls for manufacturing process changes
• Support major/trend deviation investigations throughout the whole lifecycle including Root Cause Analysis investigation, determination of Corrective/Preventive Actions, authoring process investigation reports, and presenting within regulatory inspections.
• Support Risk Assessments exercises and Microbial assessment evaluations.
• Led commercial campaign readiness and effectively communicate and collaborate with cross function areas.
• Assist in the generation of training materials and assist in providing training on scientific or technical aspects of the process.
• Provide commercial support when needed and assist on the floor troubleshooting.
• Design, coordinate, and support execution of functional tests, water tests, and other runs to challenge process and operations during major changes, or campaign readiness. Generate technical protocols as needed.
• Assist and provide guidance during MBR (Master Batch Record) creation/revisions.
• Perform assessment to support process, automation, or equipment modification or implementation of special projects
• Initiate, revise, and approve standard manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.
• Assess process performance and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities.
• Complete assessments for CAPA applicability requests from other plants/sites
• Complete assessment for new or changes in BOM's (Bill of Materials)
• Serves as a peer-recognized specialist in at least one area, with overall responsibility for determining methodologies in that area.

Education

1. Masters + 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.