Operations Process Support Specialist

Job Description About PSC Biotech Who we are? 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.   We are seeking applications for position of Operations Process Support Specialist, within Manuf./Operations for our Client Site. In this role, you will report to the Value Stream Manager and will be responsible for providing process, technical, and operations support to manufacturing team including ongoing support of manufacturing processes and support for new product introduction. You will provide cross functional and technical expertise to operations, maintenance, process support and administrative personnel and will ensure that objectives are effectively achieved, consistent with company requirements to ensure compliance, safety, and reliable supply to our customers. You will possess established experience in a process improvement role with measurable accomplishments and operational excellence achievements and will lead and actively participate in projects, system failure investigations, investigation reports, and change controls, with the ability to effectively manage project/s across multiple disciplines. Requirements What You Will Do Bring energy, knowledge, innovation, and leadership to carry out the following: 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. What Skills You Will Need In order to excel in this role, you will more than likely have: 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. #LI-PM3 Requirements What You Will Do Bring energy, knowledge, innovation, and leadership to carry out the following: 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. What Skills You Will Need In order to excel in this role, you will more than likely have: 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. #LI-PM3