Orion Group Life Sciences are currently recruiting an Operations Process Support Specialist on behalf of our Multinational Biopharmaceutical Client based in Carlow on an initial 11-Month contract with potential to extend.
Responsibilities:
Serve as a technical and operations representative for established manufacturing processes and new product introduction.
Collaborate within cross-functional teams and partner with colleagues to perform vendor management, communications, training, project work, audit/inspection duties, and ensure department readiness for audits/inspections.
Design, author, review, approve, and execute process updates in support of ongoing manufacturing support and new product introduction.
Provide technical input into quality notifications by authoring, reviewing, and approving investigations.
Drive continuous process improvements using Lean Principles to optimize equipment uptime and target outputs.
Oversee operations processes to ensure continuous, reliable, and repeatable manufacturing.
Drive effective writing, revising, and rolling out of accurate operational procedures, training materials, and manufacturing procedures.
Ensure process reliability and performance by facilitating effective systems for identifying root cause failures, making recommendations, and implementing improvement changes throughout processes.
Drive continuous improvement by leading and actively participating in system failure investigations, investigation reports, change control execution/development, and Kaizen events.
Support equipment commissioning and qualification programs representing operations.
Review and approve qualification/validation documentation and studies.
Perform data analysis and make informed decisions/recommendations based on the analysis.
Support continuous improvement through Lean Six Sigma methodologies.
Lead and actively participate in projects, system failure investigations, investigation reports, and change controls.
Perform root cause analysis using standard tools and methods to resolve machine and system issues.
Serve as a technical process representative for internal technical and operations group discussions and represent the company at global technical forums.
Participate and/or lead cross-functional or single function teams, including liaising with vendors or above site groups.
Drive compliance with company policies, procedures, and guidelines, regulatory requirements, and current Good Manufacturing Practices (cGMP).
Ensure compliance through documentation completion, risk assessments, closing out corrective actions, participation in audits and inspections, and proactive highlighting of compliance issues.
Work collaboratively to drive a safe and compliant culture.
May be required to perform other assigned duties.
Qualifications/Education
Bachelor's Degree or equivalent, ideally in a Science, Engineering or other Technical discipline
Proven track record and established experience in a process engineer role with measurable accomplishments and achievements.
Relevant experience and a particular skill set in their area of expertise that adds value to the business; ideally in a manufacturing, preferably in a GMP setting.
Knowledge of regulatory and code requirements to Irish, European, and International Codes, Standards, and Practices.
Proficiency in report, standards, and policy writing.
Proficiency in Microsoft Office and job-related computer applications.
Desired experience in Lean Six Sigma Methodology.
Excellent communication, presentation, and interpersonal skills to effectively interface with colleagues at all levels and external customers in a team-oriented manner.
Understanding of the specific responsibilities of all departments in Carlow and how they relate to one's own department, as well as understanding the business processes supported by one's department.
Progressive people management skills.
Excellent facilitation and assessment skills.
Self-motivation and flexibility.
Effective time management and multitasking skills.
Strong attention to detail and troubleshooting skills.
Goal and results oriented.
Strong change management skills.
Effective conflict resolution and negotiation skills.
Ability to effectively manage complex projects across multiple disciplines.
Our role in supporting diversity and inclusion As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.
