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.