Biotech Manufacturing Specialist: GMP & Process Leader

ProQuality Network; Juncos (PR); On-site; USD 70,000 - 110,000; Full time

Job summary

ProQuality Network is seeking a highly skilled Specialist in Manufacturing (Biotechnology) for a 6-month onsite engagement in Juncos, Puerto Rico. The role focuses on manufacturing operations, non-conformances, validation, training, and new product introductions.

The candidate will apply GMP knowledge and cross-functional collaboration to support process improvements and regulatory readiness in a fast-paced environment.

Qualifications

• Proven experience in Manufacturing Operations
• Experience with Change Control and New Product Introduction (NPI)
• Ability to lead cross-functional projects and communicate across teams
• Strong risk assessment and proactive communication

Responsibilities

• Initiate, revise, and approve manufacturing procedures and own documents.
• Establish process monitoring parameters and control limits.
• Investigate non-conformances and drive CAPA closures.
• Support process validation activities and NPI changes.
• Collaborate on process or equipment modifications.
• Contribute to continuous improvement initiatives.

Skills

Manufacturing Operations

Change Control

New Product Introductions (NPI)

Cross-functional teamwork

Risk assessment & issue escalation

Technical writing & training materials

Process validation knowledge

Education

Master’s degree in related field

Bachelor’s degree in related field

Associate degree

High school diploma or GED

Bioprocessing unit operations knowledge

GMP production environments knowledge

Regulatory standards familiarity

Job description

ProQuality Network is seeking a highly skilled Specialist in Manufacturing (Biotechnology) for a 6-month onsite engagement in Juncos, Puerto Rico. The role focuses on manufacturing operations, non-conformances, validation, training, and new product introductions.

The candidate will apply GMP knowledge and cross-functional collaboration to support process improvements and regulatory readiness in a fast-paced environment.