Manufacturing Process Specialist Lead
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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 cloudbased 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 likeminded 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 diversecultural work setting.
Employee Value Proposition
Employees are the heartbeat of PSC Biotech we provide unparalleled empowering career development though Learning & Development inhouse 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.
Job Title: Manufacturing Process Specialist Lead
An exciting and rare opportunity has presented for a Process Owner (Specialist Manufacturing) Lead at Dublin. This is a senior role in the organization and requires indepth technical and operational knowledge of aseptic Drug Product manufacturing processes; Parts/Components Preparation Formulation Syringe Filling Vial Filling Lyophilisation and Capping.
As a Process Owner Lead you will be an established professional who is a selfstarter capable of applying advanced process knowledge and creativity to complete complex assignments related to the manufacturing operations. You are someone who contributes to the development of new principles and concepts who wants to be challenged and can lead change from a manufacturing operations perspective.
Supporting key areas of the business the Process Owner Lead will direct initiatives that improve the reliability and efficiency of manufacturing processes in addition to daytoday support related to unplanned event troubleshooting investigations CAPA identification and implementation.
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 the assigned processes and taking a proactive approach to safety quality and compliance by actively seeking opportunities to remove error traps.
Accountable for process documentation (e.g. SOPs Training Electronic Batch Records Risk Assessments) in assigned area of responsibility. Gatekeeper (develop review and update) of process documentation to maintain structure and control over generation and revision ensuring the documents clearly and correctly direct the process.
Leading and/or providing input to strategic initiatives that will improve and develop processes for the future.
Contribute in a team environment to operational issues pertaining to processes as they arise and provide expertise and support to help resolve escalated technical issues as required.
Use subject matter expertise to identify and lead continuous improvement projects in assigned area of responsibility. Ensure project timelines are met challenges identified mitigations are in place and communication plans delivered to all stakeholders.
Involved in the daily business management systems and reporting have a clear understanding of what is happening in the assigned area of responsibility. Monitor any process trends including business performance metrics. Identify actions that will enable the process and the Manufacturing areas better achieve and surpass metrics in the future.
Lead and/or Support investigations that impact on safety quality and/or compliance of the processes ensuring thorough investigations are conducted and actionable CAPAs to prevent future reoccurrence are implemented within agreed timeline.
Remain current on stateoftheart for systems and processes and advise on the appropriate adoption and use of new techniques and technology.
Ability to lead change from an aseptic operations perspective is a plus.
What you need to apply:
Bachelor s degree in Science Engineering or related discipline with 5 years experience in aseptic Drug Product Manufacturing or related cGxP manufacturing experience.
Experience with regulatory compliance in cGMP manufacturing and indepth knowledge of Eudralex Volume 4 Annex 1 Manufacture of Sterile Medicinal Products.
Proven ability to work in a high paced matrix organization and effectively influence change and escalate issues professionally and in a timely manner.
Excellent DecisionMaking skills and confidence to challenge others respectfully and professionally on decisions that impact the manufacturing area.
Proactive and works well with others in a collaborative fastpaced goaldriven environment.
Interacts well with diverse groups (Manufacturing Validation Engineering Quality etc) and maintains strong working relationships with internal and external collaborators.
Demonstrated ability to coach mentor and/or cross train 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.
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 the assigned processes and taking a proactive approach to safety, quality, and compliance by actively seeking opportunities to remove error traps. Accountable for process documentation (e.g., SOPs, Training, Electronic Batch Records, Risk Assessments) in assigned area of responsibility. Gatekeeper (develop, review and update) of process documentation to maintain structure and control over generation and revision ensuring the documents clearly and correctly direct the process. Leading and/or providing input to strategic initiatives that will improve and develop processes for the future. Contribute in a team environment to operational issues pertaining to processes as they arise and provide expertise and support to help resolve escalated technical issues as required. Use subject matter expertise to identify and lead continuous improvement projects in assigned area of responsibility. Ensure project timelines are met, challenges identified, mitigations are in place and communication plans delivered to all stakeholders. Involved in the daily business management systems and reporting, have a clear understanding of what is happening in the assigned area of responsibility. Monitor any process trends including business performance metrics. Identify actions that will enable the process and the Manufacturing areas better achieve and surpass metrics in the future. Lead and/or Support investigations that impact on safety, quality and/or compliance of the processes, ensuring thorough investigations are conducted and actionable CAPAs, to prevent future reoccurrence, are implemented within agreed timeline. Remain current on state-of-the-art for systems and processes and advise on the appropriate adoption and use of new techniques and technology. Ability to lead change from an aseptic operations perspective is a plus. What you need to apply: Bachelor s degree in Science, Engineering or related discipline with 5 + years experience in aseptic Drug Product Manufacturing or related cGxP manufacturing experience. Experience with regulatory compliance in cGMP manufacturing and in-depth knowledge of Eudralex Volume 4, Annex 1 Manufacture of Sterile Medicinal Products. Proven ability to work in a high paced matrix organization and effectively influence change and escalate issues professionally and in a timely manner. Excellent Decision-Making skills and confidence to challenge others respectfully and professionally on decisions that impact the manufacturing area. Proactive and works well with others in a collaborative, fast-paced goal-driven environment. Interacts well with diverse groups (Manufacturing, Validation, Engineering, Quality etc) and maintains strong working relationships with internal and external collaborators. Demonstrated ability to coach, mentor and/or cross train 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. #LI-BR1
Employment Type
Full Time
