Manufacturing Process Specialist Lead

• Industry Pharma/Biotech/Clinical Research
• Work Experience 5+ years
• City Dublin
• State/Province Dublin
• Country Ireland

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 points 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. JobTitle: Manufacturing Process Specialist Lead Summary: An exciting and rare opportunity has presented fora Process Owner (Specialist Manufacturing) Lead at Dublin. This is a seniorrole in the organization and requires in-depth technical and operationalknowledge of aseptic Drug Product manufacturing processes; Parts/ComponentsPreparation, Formulation, Syringe Filling, Vial Filling, Lyophilisation andCapping. As a Process Owner Lead, you will be anestablished professional who is a self-starter, capable of applying advancedprocess knowledge and creativity to complete complex assignments related to themanufacturing operations. You are someone who contributes to the development ofnew principles and concepts, who wants to be challenged and can lead changefrom a manufacturing operations perspective. Supporting key areas of the business, the ProcessOwner Lead will direct initiatives that improve the reliability and efficiencyof manufacturing processes in addition to day-to-day support related tounplanned event troubleshooting, investigations, CAPA identification andimplementation.

Requirements

Primary responsibilities: Perform as a knowledgeable subject matter expert(SME), and single point of contact on site and network projects and programs,to advance manufacturing and aseptic operations through ownership of theassigned processes and taking a proactive approach to safety, quality, andcompliance by actively seeking opportunities to remove error traps. Accountable for process documentation (e.g., SOPs,Training, Electronic Batch Records, Risk Assessments) in assigned area ofresponsibility. Gatekeeper (develop, review and update) of processdocumentation to maintain structure and control over generation and revisionensuring the documents clearly and correctly direct the process. Leading and/or providing input to strategicinitiatives that will improve and develop processes for the future. Contribute in a team environment to operationalissues pertaining to processes as they arise and provide expertise and supportto help resolve escalated technical issues as required. Use subject matter expertise to identify and leadcontinuous improvement projects in assigned area of responsibility. Ensureproject timelines are met, challenges identified, mitigations are in place andcommunication plans delivered to all stakeholders. Involved in the daily business management systemsand reporting, have a clear understanding of what is happening in the assignedarea of responsibility. Monitor any process trends including businessperformance metrics. Identify actions that will enable the process and theManufacturing areas better achieve and surpass metrics in the future. Lead and/or Support investigations that impact onsafety, quality and/or compliance of the processes, ensuring thoroughinvestigations are conducted and actionable CAPAs, to prevent futurereoccurrence, are implemented within agreed timeline. Remain current on state-of-the-art for systems andprocesses and advise on the appropriate adoption and use of new techniques andtechnology. Ability to lead change from an aseptic operationsperspective is a plus. What you need to apply: Bachelor’s degree in Science, Engineering orrelated discipline with 5 + years’ experience in aseptic Drug ProductManufacturing or related cGxP manufacturing experience. Experience with regulatory compliance in cGMP manufacturingand in-depth knowledge of Eudralex Volume 4, Annex 1 Manufacture of SterileMedicinal Products. Proven ability to work in a high paced matrix organizationand effectively influence change and escalate issues professionally and in atimely manner. Excellent Decision-Making skills and confidence tochallenge others respectfully and professionally on decisions that impact themanufacturing area. Proactive and works well with others in acollaborative, fast-paced goal-driven environment. Interacts well with diverse groups (Manufacturing,Validation, Engineering, Quality etc) and maintains strong workingrelationships with internal and external collaborators. Demonstrated ability to coach, mentor and/or crosstrain colleagues within core technical areas. Excellent verbal and written communication skills:Strong Technical writing skills for cGxP documentation (e.g., investigations,procedures, change controls) and good Presentation skills. #J-18808-Ljbffr