Field Service Engineer

JOB DESCRIPTION
COMPANY OVERVIEW
We are a leading provider of pharmaceutical and biotechnology engineering solutions, specialising in validation, qualification, and maintenance of critical equipment. Our team is dedicated to supporting the pharmaceutical manufacturing process by ensuring equipment meets the highest standards of regulatory compliance and operational reliability. With a strong emphasis on quality and precision, we work closely with industry leaders to maintain safe and efficient
operations across their facilities.

POSITION OVERVIEW
The Field Service Engineer for Pharmaceutical Validation and Qualification will focus on the installation, validation, and qualification of autoclaves used in sterile manufacturing environments. Reporting to the company director, this role requires travel to client sites and involves hands-on troubleshooting, equipment calibration, and validation protocol execution. This role is crucial in ensuring that equipment meets all regulatory requirements, particularly for critical processes within sterile and aseptic environments.

RESPONSIBILITIES

• Conduct installation, operational, and performance qualification (IQ/OQ/PQ)
  activities for autoclaves and other sterilization equipment in pharmaceutical
  environments.
• Develop and execute validation protocols in compliance with cGMP, FDA, and
  other regulatory guidelines, ensuring all work meets stringent industry
  standards.
• Perform regular maintenance, calibration, and troubleshooting of autoclaves,
  maintaining equipment integrity and performance.
• Create and manage detailed validation documentation, including calibration
  records, testing reports, and validation summaries.
• Work closely with Quality Assurance, Regulatory, and Engineering teams to
  ensure compliance with internal standards and client-specific requirements.
• Provide on-site training to operators and technicians on autoclave use,
  maintenance, and standard operating procedures.
• Support client audits and regulatory inspections by providing technical
  expertise and relevant documentation.
• Stay current with industry trends, regulatory changes, and new technologies
  related to pharmaceutical sterilization and autoclave validation.
• Maintain a high level of customer service, working with clients to address questions and providing timely updates on validation project progress.

QUALIFICATIONS

• 3+ years of field service experience in pharmaceutical or biotech equipment
  validation, with a focus on autoclaves or sterilization equipment.
• Proficiency in validation standards and procedures (IQ/OQ/PQ) for pharmaceutical environments.
• Excellent troubleshooting skills, with the ability to diagnose and resolve mechanical and software-related issues in autoclave systems.
• Effective communication and interpersonal skills for on-site collaboration with clients and internal teams.
• Willingness to travel extensively to client sites, with the flexibility to manage a varied and dynamic schedule.
• Proficiency in using calibration tools and related software, along with a strong understanding of quality management systems (QMS).

OPPORTUNITY
This position offers the opportunity to play a pivotal role in maintaining high standards of equipment performance and regulatory compliance within the pharmaceutical industry. As a Field Service Engineer, you will gain in-depth knowledge of validation processes and have the chance to work with top-tier clients, driving both your professional growth and the success of our clients’ critical operations.