GMP Manufacturing Tech Transfer Specialist II

PCI TRGR Penn Pharmaceutical Services Ltd; Bedford (NH); Hybrid; USD 70,000 - 110,000; Full time

Benefits offered by this job

Competitive rewards program

Job summary

PCI Pharma Services in New Hampshire seeks a Manufacturing Technical Specialist to provide technical knowledge for GMP manufacturing, regulatory compliance, and direct client support. You will author batch records and SOPs, support quality systems, investigations, and CAPA execution, and work with aseptic and non-aseptic operations.

The role requires 3+ years in a technical or GMP manufacturing setting, strong cGMP knowledge, and excellent written communication. Travel <10% may be required.

Qualifications

• Three 3+ years of experience in either a technical or manufacturing role or 3+ years of GMP experience in a regulated industry (pharmaceutical, biotech or medical device)
• Knowledge of biopharmaceutical and/or medical product formulation, filtration and filling operations
• Proficiency with MS Office (Word/Excel/Access/ PowerPoint/One Note)

Responsibilities

• Provide technical support for transfer of new processes with minimal supervision
• Author Production Batch Record modules and SOPs for new processes and revise existing records
• Conduct complex investigations and document revisions for batch records and procedures
• Assist in material specification and cross-functional team collaboration
• Maintain production records compliance and train manufacturing personnel on quality systems

Skills

GMP knowledge and applications

Technical writing

Root cause analysis

Investigations and CAPA execution

MS Office

Education

Bachelor's or Associate degree in life science or related field

Tools

GMP batch records system

SOP authoring

Job description

PCI Pharma Services in New Hampshire seeks a Manufacturing Technical Specialist to provide technical knowledge for GMP manufacturing, regulatory compliance, and direct client support. You will author batch records and SOPs, support quality systems, investigations, and CAPA execution, and work with aseptic and non-aseptic operations.

The role requires 3+ years in a technical or GMP manufacturing setting, strong cGMP knowledge, and excellent written communication. Travel <10% may be required.