Pharma Manufacturing Specialist: cGMP & Process Improvement

Mirus Consulting Group; Juncos (PR); On-site; USD 85,000 - 110,000; Full time

Job summary

mîrus Consulting Group, based in Humacao, Puerto Rico, seeks a Manufacturing Specialist to support regulated pharma operations. You’ll ensure cGMP compliance, maintain documentation, and drive process improvements while collaborating cross-functionally to sustain product quality and regulatory readiness.

The role includes developing procedures, owning change control, and supporting validation activities, training, and inspections, with a focus on efficiency and compliance in a dynamic

Qualifications

• Doctorate or master/bachelor with manufacturing operations experience in regulated environments.
• Experience with cGMP, FDA regulations, and validation.
• Experience with Electronic Batch Records (EBR) and change controls.

Responsibilities

• Initiate, revise, and approve manufacturing procedures; act as document owner.
• Assess process performance and implement improvements.
• Assist in training materials and deliver training on technical aspects.
• Ensure processes align with cGMP and applicable regulations.
• Own Change Control and support CCRB packages affecting the process.
• Participate in regulatory inspections and NPI documentation and equipment changes.
• Support process validation protocols and reports; contribute to data analysis.

Skills

cGMP

Process improvement

Documentation

Regulatory inspections

Electronic Batch Records

Change control

Project management

Data analysis

Cross-functional collaboration

Technical writing

Education

Doctorate degree

Master's degree + 2 years experience

Bachelor's degree + 4 years experience

Tools

EBR systems

Job description

mîrus Consulting Group, based in Humacao, Puerto Rico, seeks a Manufacturing Specialist to support regulated pharma operations. You’ll ensure cGMP compliance, maintain documentation, and drive process improvements while collaborating cross-functionally to sustain product quality and regulatory readiness.

The role includes developing procedures, owning change control, and supporting validation activities, training, and inspections, with a focus on efficiency and compliance in a dynamic