Engineering Compliance Specialist

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

• Industry Pharma/Biotech/Clinical Research
• Work Experience 4-5 years
• City Carlow
• State/Province Carlow
• Country Ireland

Job Description

About PSC Biotech

Who are we?

PSC Biotech is a leading Biotech Consultancy firm foundedin 1996, headquartered in Pomona, California, USA, with Global operations inIreland, India, Singapore, Australia and the US, serving 350 clients in morethan 23 countries worldwide. We provide cloud-based software solutions forQuality Management and Regulatory Inspections, pharmaceuticals contractmanufacturing professionals, and metrology services to our clients.

Take your Career to a new Level

PSC Biotech disrupts the conventional consultancy modelby aligning our EVP as one of the unique selling point which includes theopportunity to work with the most talented cohort of like-minded professionalsoperating in the Pharma/ Biotech Industry. We offer a permanent contract ofemployment giving exposure of working in Top Pharmaceutical client sites in adiverse-cultural work setting.

Employee Value Proposition

Employees are the heartbeat of PSC Biotech, we provideunparalleled empowering career development though Learning & Developmentin-house training mentorship through constant guidance to facilitate careerprogression. We believe in creating high performing teams that can exceed ourclient's expectations with regards to quality of all scalable and business unitdeliverables, staying under budget and ensuring timelines for our deliverablesare being met.

Overview:

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

11 Months of Contract

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

Requirements

What you will do:

• Bring energy, knowledge, innovation, and leadership to carry out the following:
  
• Direct and/lead deviations, out of tolerance conditionsand unexpected results, conducting failure analysis, root cause determinationand 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 otherdepartments particularly IPT, Quality, EHS, Technical Engineering in completionof tasks and maintaining compliance posture.
  
• Required to comply with GlobalPolicies, ProceduresandGuidelines, regulatory requirements and execute current Goodmanufacturing Practices (cGMP) in the performance of day-to-day activities andall applicable job functions. Work collaboratively to drive a safe andcompliant 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 likelyhave:
  
• Diploma or higher preferred, ideally in a relateddiscipline.
  
• Would typically have prior-related work experience;ideally in a manufacturing GMP setting.
  
• Effective communication and interpersonal skills tointerface effectively with all levels of colleagues in a team environment
  
• Knowledge of regulatory/code requirements to Irish,European and International Codes, Standards and Practices
  
• Sterile filling processes and equipment experiencepreferred.
  
• Proficiency in Microsoft Office and job-related computerapplications
  
• Effective communication and interpersonal skills tointerface effectively with all levels of colleagues in a team environment, andwith external customers
  
• Understand the specific responsibilities of all departmentsas they relate to one’s own department, understanding the business processesone’s department supports
  
• Effective time management and multi-tasking skills