We are seeking a highly motivated Process Equipment Engineer to join our client's Biologics Operations team.
Key Responsibilities
* Review and approve PFDs, P&IDs, layouts, and specifications to ensure compliance.
* Lead FAT/SAT activities and oversee vendor interactions to guarantee site and regulatory requirements are met.
* Support equipment integration, installation, commissioning, and validation, including troubleshooting and technical resolutions.
Operational Support:
* Develop and update procedures to align with manufacturing and regulatory needs, focusing on process optimization and maintenance strategies.
* Troubleshoot equipment issues, investigate process deviations, and coordinate technical resolutions to ensure ongoing equipment performance.
* Ensure adherence to maintenance strategies and ongoing equipment performance, identifying areas for improvement.
Validation & Compliance:
* Develop commissioning and validation strategies following Good Engineering Practice (GEP) and review validation protocols to ensure project timelines are met.
* Execute validation protocols, ensuring alignment with project timelines and cGMP, ISO, and FDA standards.
* Maintain readiness for audits and inspections by upholding high standards of quality and regulatory compliance.
Collaboration & Leadership:
* Work closely with cross-functional teams, including Operations, Quality, and S&T, to support equipment lifecycle management.
* Mentor and provide guidance to peers and contractors, leading training sessions as needed to drive continuous improvement.
* Drive cost-saving initiatives and new technology integration, promoting innovation within the organization.
Qualifications
* Bachelor's or Master's degree in Engineering, Science, or a related technical discipline is required.
* A minimum of 5 years' experience in equipment or process engineering within the pharmaceutical or biotech sector is necessary.
* At least 3 years' experience in GMP manufacturing environments is preferred, along with knowledge of parenteral drug manufacturing, sterilization, and aseptic processing.
* Experience with new product introduction and tech transfer is advantageous.
Skills and Competencies
* Strong problem-solving ability under pressure and attention to detail are essential.
* Excellent verbal and written communication skills, interpersonal skills, and stakeholder management capabilities are required.
* Able to work independently and make informed technical decisions, demonstrating a high level of integrity and commitment to quality.
* Familiarity with automation/control systems and their impact on processes is beneficial.
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 sessions.
* May supervise contractors or lead cross-functional project teams, interacting with vendors, engineers, and auditors as needed.