Senior Sterile Manufacturing and Microbiology Consultant

Weil Group, Inc; Manatí (PR); Sur place; USD 120 000 - 180 000; Plein temps

Résumé du poste

Weil Group Inc. in Manatí, Puerto Rico, seeks a Senior Sterile Manufacturing and Microbiology Consultant to join a potential pharmaceutical manufacturing quality-system assessment.

You will evaluate sterile-manufacturing and microbiological evidence to support batch disposition within the confirmed scope. Responsibilities include linking microbiological records to batches, reviewing environmental and sterility-related evidence, and identifying practical improvements with Quality and operations.

Qualifications

• Hands-on experience in sterile pharmaceutical manufacturing and microbiological evidence evaluation.
• Ability to assess records supporting microbiological quality and batch-disposition decisions.
• Experience connecting relevant operations, monitoring events, deviations and batch impact.
• Professional English for technical records, deliverables and stakeholder discussions.

Responsabilités

• Connect relevant microbiological and contamination-control records to the affected batches and operations.
• Assess review of environmental, process or sterility-related evidence as applicable.
• Identify supported gaps and practical improvements with Quality and operations.

Connaissances

Sterile pharmaceutical manufacturing

Microbiological evidence evaluation

Formation

Microbiology, pharmacy, science or engineering education

Description du poste

Senior Sterile Manufacturing and Microbiology Consultant

• Manati, PR
• Biotech/Pharmaceutical

Weil Group Inc. is identifying specialists for potential assignments within a proposed pharmaceutical manufacturing quality-system assessment. This opportunity is subject to confirmed specialist scope, project award and client confirmation.

Evaluate sterile-manufacturing and microbiological evidence relevant to batch disposition when these processes are included in the confirmed scope.

What you will do

• Connect relevant microbiological and contamination-control records to the affected batches and operations.
• Assess review of environmental, process or sterility-related evidence as applicable.
• Identify supported gaps and practical improvements with Quality and operations.

Mandatory requirements

• Hands-on experience in sterile pharmaceutical manufacturing and microbiological evidence evaluation.
• Ability to assess records supporting microbiological quality and batch-disposition decisions.
• Experience connecting relevant operations, monitoring events, deviations and batch impact.
• Professional English for technical records, deliverables and stakeholder discussions.
• Availability for assigned on-site work in Manatí, Puerto Rico, with approved remote work where appropriate.
• Ability to meet confidentiality, site and information-handling requirements and disclose potential conflicts affecting independent assessment.

Necessary qualifications

• Typically 7 or more years of directly relevant professional experience, or a demonstrably equivalent track record.
• Apply sterile-manufacturing and contamination-control requirements appropriate to the confirmed process, including EU GMP Annex 1 where applicable.
• Understand original microbiology records, review practices and relevant aseptic operations.
• Relevant microbiology, pharmacy, science or engineering education, or equivalent practical experience.

Desired qualifications

• Experience with the aseptic technology and monitoring systems used at the site.
• Contamination-control strategy assessments or sterile-process improvement projects.
• Relevant sterile-manufacturing auditing or inspection-support experience.

**Weil Group is proud to be an Equal Employment Opportunity Employer.**