Back to Job SearchROLE OVERVIEW
An exciting opportunity for a Global Process Expert to join a leading pharmaceutical organization supporting sterile fill-finish equipment on a global scale. This role is based within a dynamic engineering, sites, and facilities team dedicated to developing and maintaining technical standards, fostering international collaboration, and ensuring project excellence across multiple sites.
Our client seeks a highly experienced professional to provide expert-level support and drive continuous improvement initiatives within the drug product manufacturing sphere. The successful candidate will play a pivotal role in shaping engineering standards related to sterile filling equipment and contribute to a global network of technical experts.
KEY DUTIES AND RESPONSIBILITIES
Your duties as the Global Process Expert will be varied; however, the key responsibilities are as follows:
- As the Global Process Expert, you will develop and maintain technical engineering standards specifically for drug product process equipment, with a focus on sterile fill-finish systems.
- As the Global Process Expert, you will act as the authoritative reference for sterile fill-finish equipment and dry forms drug product design across global sites.
- As the Global Process Expert, you will provide technical support by answering complex questions, conducting technical reviews, and contributing to project phases from feasibility through detailed design.
- As the Global Process Expert, you will coordinate with other technical experts and serve as a backup on process engineering design and clean utilities topics.
- As the Global Process Expert, you will participate actively in global expert networks, bringing in external best practices, and supporting adherence to cGxP/EHS regulations.
- As the Global Process Expert, you will promote innovation, digitalization, and continuous improvement in equipment lifecycle management.
ROLE REQUIREMENTS
To be successful in your application to this exciting role as the Global Process Expert we are looking to identify the following on your profile and past history:
- A Degree or higher level in a relevant field (e.g., Pharmaceutical Chemistry / Quality Assurance / Quality Management for QA roles).
- Proven extensive experience (8+ years) within pharmaceutical process engineering, specifically in sterile drug product fill-finish equipment, across multiple project phases.
- Strong expertise in sterile fill-finish systems, with solid knowledge of general process engineering design principles.
- Experience working within the pharmaceutical industry, with full professional proficiency in English and French (written and spoken).
- Ability to work independently, handle complex technical topics, and effectively manage time across multiple priorities.
Key Words: pharmaceutical / drug / drug product / drug substance / process engineering / process engineer / global process expert / SME / subject matter expert / sterile / aseptic / sterile manufacturing / aseptic processing / fill-finish / fill finish / filling lines / injectable / injectables / vials / syringes / cartridges / lyophilisation / freeze drying / isolators / RABS / barrier systems / autoclaves / depyrogenation / cleanrooms / Grade A / Grade B / Annex 1 / sterile design / equipment design / process design / engineering design / CAPEX / capital projects / project engineering / technical authority / technical standards / standards development / global standards / governance / lifecycle management / equipment lifecycle / technology transfer / tech transfer / MSAT / CQV / commissioning / qualification / validation / DQ / IQ / OQ / PQ / FAT / SAT / URS / GMP / cGMP / GxP / EHS / HAZOP / risk assessment / FMEA / deviation / CAPA / change control / audit / inspection readiness / FDA / EMA / ICH / ISPE / clean utilities / WFI / clean steam / CIP / SIP / HVAC / process utilities / pharmaceutical manufacturing / biologics / vaccines / small molecules / biotech / CDMO / CMO / manufacturing science / engineering / process optimisation / continuous improvement / operational excellence / digitalisation / MES / SCADA / DeltaV / Siemens / automation / data integrity / global projects / multi-site / international collaboration / stakeholder management / technical leadership / troubleshooting / scale-up / facility design / plant design / greenfield / brownfield
"Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career."
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
