Engineering Compliance Specialist

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

About PSC Biotech

Who are we?

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

‘Take your Career to a new Level’

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

Employee Value Proposition

Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.

Overview:

We are seeking an Engineering Compliance Specialist to join our Engineering Department , supporting operations in a GMP and Sterile Environment. This role is essential for ensuring compliance, safety, and reliable product supply. Key responsibilities include generating and expediting the review of Manufacturing GMP documentation such as deviation reports (QNs) and corrective and preventative actions (CAPAs), leading Engineering change controls and supporting permanent inspection readiness. The Compliance Specialist will also author, edit, and review controlled documents, collaborate within cross-functional teams to solve problems using Root Cause Analysis (RCA) methodologies, and ensure timely completion of documentation to maintain compliance with regulatory requirements.

11 Months of Contract

Remote/Hybrid/Onsite: Initially 4 days onsite - could move to 3 after 6 months

What you will do:

• Bring energy, knowledge, innovation, and leadership to carry out the following:
• Direct and/lead deviations, out of tolerance conditions and unexpected results, conducting failure analysis, root cause determination and implementing corrective and preventative actions.
• Supporting Engineering documentation review - e.g. electronic logs
• Supporting Audit Readiness activities.
• Supporting Internal Audit programs
• Collaborate with Engineering colleagues and other departments particularly IPT, Quality, EHS, Technical Engineering in completion of tasks and maintaining compliance posture.
• Required to comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions. Work collaboratively to drive a safe and compliant culture
• May be required to perform other duties as assigned.

What skills you will need:

• In order to excel in this role, you will more than likely have:
• Diploma or higher preferred, ideally in a related discipline.
• Would typically have prior-related work experience; ideally in a manufacturing GMP setting.
• Effective communication and interpersonal skills to interface effectively with all levels of colleagues in a team environment
• Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
• Report, standards, policy writing skills
• Sterile filling processes and equipment experience preferred.
• Proficiency in Microsoft Office and job-related computer applications
• Lean Six Sigma Methodology experience
• Effective communication and interpersonal skills to interface effectively with all levels of colleagues in a team environment, and with external customers
• Understand the specific responsibilities of all departments as they relate to one’s own department, understanding the business processes one’s department supports
• Effective time management and multi-tasking skills
• Proven organizational skills
• Excellent attention to detail