Compliance Engineer

Job Title: Compliance Engineer

Start Date: ASAP

Duration: 11 months

Contract Type: Fixed Term Contract

Remote Role Y/N: Hybrid

Role Description

Responsible for supporting the Engineering Department in a GMP and Sterile Environment. Ensure that objectives are effectively achieved, consistent with requirements to ensure compliance, safety and reliable supply to our customers.

Role Functions

Principal Accountabilities: – Direct and/lead deviations, out of tolerance conditions and unexpected results, conducting failure analysis, root cause determination and implementing corrective actions. – Preparation and analysis of Engineering metrics reports to trend for improved operational efficiencies. – Format, write, deliver and review necessary documentation in line with the standard approval process, and facilitate others to do so. Documents will include SOP’s, SWI’s, training documents, JSA’s, PM’s and change controls. – Accountable for leading investigation analysis, identifying true root cause, identifying gaps and actions to close gaps. Collaborate with Engineering colleagues and other departments particularly IPT, Quality, EHS, Technical Engineering in completion of tasks. – 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 in Carlow. May be required to perform other duties as assigned – Support Audit Readiness activities

Experience

• Technical 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 required Sterile filling processes and equipment experience preferred. Proficiency in Microsoft Office and job related computer applications required Lean Six Sigma Methodology experience desired
• Business 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 Carlow departments as they relate to one’s own department, understanding the business processes ones department supports Customer service Self-motivated Flexible approach Effective time management and multi-tasking skills Proven organizational skills Excellent attention to detail Data analysis Training skills Starter, finisher Trouble shooting skills Goal/results orientated
• Leadership Focus on Customers and Patients Collaborate Act with Candor and Courage Make Rapid, Disciplined Decisions Drive Results Build Talent Demonstrate Ethics and Integrity
• Diploma or higher preferred, ideally in a related discipline.
• Would typically have prior related work experience; ideally in a manufacturing, preferably GMP setting.