Biologics Process Equipment Engineer
We are seeking a highly motivated
Process Equipment Engineer
to join our clients
Biologics Operations
team. This role supports the design, commissioning, validation, and lifecycle management of manufacturing equipment, ensuring alignment with safety, quality, and regulatory standards. The successful candidate will act as the equipment SME from the design phase through to handover, supporting both ongoing operations and new product introductions.
KEY RESPONSIBILITIES
PROJECT & PROCESS ENGINEERING:
* Act as SME 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.
OPERATIONAL SUPPORT:
* 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.
VALIDATION & COMPLIANCE:
* 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.
COLLABORATION & LEADERSHIP:
* Work closely with cross-functional teams (Operations, Quality, S&T) 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.
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.
SKILLS AND COMPETENCIES
* Strong problem-solving ability under pressure.
* Detail-oriented with a focus on compliance and operational excellence.
* Excellent verbal and written communication skills.
* Strong interpersonal and stakeholder management capabilities.
* Ability to work independently and make informed technical decisions.
* High level of integrity and commitment to quality.
* Familiarity with automation/control systems and their impact on processes.
ADDITIONAL EXPECTATIONS
* Support EHS policies, actively report incidents or unsafe conditions, and contribute to a safe working environment.
* 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.