GMP Compliance Engineer - Hybrid/Remote

PSC Biotech Corporation; Carlow; Hybrid; EUR 67,000 - 89,000; Full time

Job summary

PSC Biotech Corporation is seeking an Engineering Compliance Specialist to support GMP operations in a sterile environment, ensuring compliance and reliable product supply. You will review deviation reports, support CAPAs, and lead change controls while collaborating across cross-functional teams.

The role emphasizes document editing, regulatory alignment to Irish/European standards, and readiness for inspections, with an initial 4 days onsite arrangement that may move to 3 days after six months.

Qualifications

• Diploma or higher in a related discipline is preferred.
• Prior experience in a GMP manufacturing setting is desirable.
• Strong written and verbal communication skills are required.
• Knowledge of Irish, European and International regulatory codes is helpful.
• Experience with sterile filling processes and equipment is a plus.

Responsibilities

• Direct and lead deviations, out-of-tolerance conditions and root-cause analysis.
• Support engineering documentation review, including electronic logs.
• Assist with audit readiness activities and internal audit programs.
• Collaborate with IPT, Quality, EHS and Technical Engineering to maintain compliance.
• Ensure adherence to cGMP and regulatory requirements in day-to-day duties.

Skills

GMP knowledge

Regulatory knowledge

Communication

Time management

Team interfacing

Multi-tasking

Education

Diploma or higher

Tools

Microsoft Office

Job description

PSC Biotech Corporation is seeking an Engineering Compliance Specialist to support GMP operations in a sterile environment, ensuring compliance and reliable product supply. You will review deviation reports, support CAPAs, and lead change controls while collaborating across cross-functional teams.

The role emphasizes document editing, regulatory alignment to Irish/European standards, and readiness for inspections, with an initial 4 days onsite arrangement that may move to 3 days after six months.