GMP Compliance Engineer - Remote/Hybrid

PSC Biotech® Corporation; Carlow; Hybrid; EUR 50,000 - 80,000; Full time

Job summary

PSC Biotech Corporation in Ireland seeks an Engineering Compliance Specialist to join our Engineering Department, supporting operations in a GMP and sterile environment.

Initial 4 days onsite, potentially moving to 3 days after 6 months, with a remote/hybrid/on-site work arrangement. The role focuses on deviation review, CAPA, change controls, and ensuring regulatory compliance for manufacturing activities.

Qualifications

• Diploma or higher in a related discipline preferred.
• Prior-related work experience in a GMP manufacturing setting is desirable.
• Knowledge of Irish, European and International regulatory/code requirements, standards and practices.
• Strong report, policy and standard-writing skills.
• Experience with sterile filling processes and equipment is preferred.

Responsibilities

• Direct and lead deviations and CAPA work, conduct root cause analysis, and implement corrective/preventive actions.
• Support engineering documentation review, including electronic logs.
• Assist audit readiness activities and internal audit programs.
• Collaborate with cross-functional teams to maintain compliance posture.
• Comply with global policies, procedures, and guidelines and uphold cGMP in daily tasks.
• Perform other duties as assigned.

Skills

Diploma or higher

Effective communication

Regulatory knowledge

Report writing

Sterile filling processes

Microsoft Office

Lean Six Sigma

Time management

Multi-tasking

Organizational skills

Attention to detail

Education

Diploma or higher

Tools

Microsoft Office

Job-related computer applications

Job description

PSC Biotech Corporation in Ireland seeks an Engineering Compliance Specialist to join our Engineering Department, supporting operations in a GMP and sterile environment.

Initial 4 days onsite, potentially moving to 3 days after 6 months, with a remote/hybrid/on-site work arrangement. The role focuses on deviation review, CAPA, change controls, and ensuring regulatory compliance for manufacturing activities.