Job Title:
Process Equipment Specialist.
We are seeking a highly motivated engineer to join our operations team, responsible for supporting the design, commissioning and validation of manufacturing equipment, ensuring alignment with safety, quality and regulatory standards.
Key Responsibilities:
* Act as subject matter expert for vial filling and isolator systems from design to validation.
* Review and approve PFDs, P&IDs, layouts and specifications.
* Lead FAT/SAT activities and oversee vendor interactions to ensure compliance with site and regulatory requirements.
* Support equipment integration, installation, commissioning and validation.
* Develop and update procedures to align with manufacturing and regulatory needs.
* Troubleshoot equipment issues, investigate process deviations and coordinate technical resolutions.
* Ensure ongoing equipment performance, process optimization and adherence to maintenance strategies.
* Develop commissioning and validation strategies following Good Engineering Practice (GEP).
* Review and execute validation protocols ensuring alignment with project timelines.
* Ensure readiness for audits and inspections by upholding cGMP, ISO and FDA standards.
* Work closely with cross-functional teams to support equipment lifecycle.
* Mentor and provide guidance to peers and contractors; lead training where applicable.
* Drive continuous improvement and support cost-saving initiatives and new technology integration.
Required Skills and Qualifications:
* Bachelor's or Master's degree in Engineering, Science or a related technical discipline.
* Minimum 5 years of experience in equipment or process engineering within the pharmaceutical or biotech sector.
* At least 3 years' experience in GMP manufacturing environments.
* Knowledge of parenteral drug manufacturing, sterilisation and aseptic processing is highly desirable.
* Experience with new product introduction and tech transfer is advantageous.
Addition Expectations:
* Support EHS policies, actively report incidents or unsafe conditions and contribute to a safe working environment.
* We wear appropriate PPE and attend all required safety and compliance training.
* May supervise contractors or lead cross-functional project teams.
* Will have external contact with vendors, engineers and auditors.