Specialist Manufacturing - Aseptic Process Owner

Overview

We have an exceptional opening for an experienced Aseptic Process Owner, a vital role demanding comprehensive technical and operational expertise in aseptic drug product manufacturing. This includes extensive knowledge in parts/components preparation, formulation, syringe and vial filling, lyophilisation, and capping processes.

As the Aseptic Process Owner, you will expand the site's aseptic processing expertise, representing the site globally within the manufacturing network. This position requires a seasoned self-starter who applies advanced processes creatively to address complex aseptic operational challenges, driving innovation and transformation from the aseptic operations perspective.

Key Responsibilities

• Act as the site's and network's subject matter expert and primary contact for projects and programs advancing aseptic operations.
• Lead or contribute significantly to strategic initiatives aiming to enhance manufacturing processes, with a focus on contamination control and aseptic process simulations.
• Collaborate in team settings to address operational process issues, offering expertise to resolve technical escalations efficiently.
• Stay updated on cutting-edge systems and methodologies, advising on the integration of new technologies and techniques.
• Engage in daily business management, maintaining clear insight into assigned operational areas.
• Monitor process trends including personnel and environmental monitoring and analyse business performance metrics.
• Propose actionable measures to improve processes and manufacturing performance beyond current benchmarks.
• Lead or assist with investigations and risk-based decisions affecting safety, quality, or compliance, ensuring thorough root cause analysis and implementation of corrective actions within deadlines.

Required Qualifications and Skills

• Bachelor's degree in Microbiology or a related field coupled with over five years of experience in sterile pharmaceutical manufacturing.
• Strong familiarity with cGMP regulatory compliance and in-depth understanding of Eudralex Volume 4, Annex 1 for sterile medicinal product production and its practical application.
• Proven capability to operate effectively within a dynamic, matrix-structured organization, adept at influencing change and escalating issues professionally.
• Exceptional decision-making aptitude and the confidence to challenge decisions impacting manufacturing areas in a professional manner.
• Collaborative approach with a proactive attitude thriving in fast-paced and goal-oriented environments.
• Ability to engage positively with diverse groups such as Manufacturing, Validation, Engineering, and Quality, maintaining robust professional relationships internally and externally.
• Experience in coaching, mentoring, or cross-training peers in core technical domains.
• Outstanding verbal and written communication skills, including technical writing for cGxP documentation such as investigations, procedures, and change controls, along with strong presentation abilities.