Specialist - Manufacturing

• 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.

• 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.

Berkley Group