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Validation Project Engineer in Biotechnology
3 months ago
Validation Engineer - Contract Opportunity
Are you an experienced Validation Engineer with a background in the biotechnology sector or aseptic pharmaceutical environments? This contract position offers a unique chance to work in a leading international biotechnology firm.
Position OverviewOur client is a prominent player in the biotechnology field, renowned for its advanced aseptic manufacturing capabilities. The facility is currently expanding, presenting an excellent opportunity for professionals looking to enhance their expertise in a dynamic environment.
The Project / Equipment Engineer will report directly to the Senior Manager for Engineering Projects and will be responsible for:
- Defining and executing technical projects that support Drug Product manufacturing across various stages including Formulation, Component Preparation, Vial/Syringe Filling, and Lyophilisation.
- Qualification of new machinery and the establishment of reliability and maintenance protocols.
- Managing and executing assigned projects, including prioritization, resource allocation, status tracking, and communication with external parties.
- Collaborating with diverse stakeholders to outline project scopes and ensure all requirements are met from concept through to operation.
- Facilitating the introduction of new processes, equipment, and materials while addressing and resolving equipment issues prior to qualification and startup.
- Creating and implementing maintenance strategies and optimizing spare parts inventory for new equipment.
- Translating strategic technology solutions into actionable plans.
- Overseeing change control processes.
- Participating as a key member of multidisciplinary teams across multiple sites.
- Drafting detailed specifications, engineering documents, protocols, and standard operating procedures.
- Working closely with System Owners, Maintenance Supervisors, Technicians, Capital Project Engineers, and Vendors to upgrade or retrofit equipment.
- Ensuring compliance with Good Manufacturing Practices and company policies while performing all tasks with due diligence.
- Promoting a safe work environment by adhering to health and safety regulations.
Education: Bachelor’s Degree in Engineering (Mechanical, Electrical, or Chemical) or equivalent experience.
Experience: A minimum of 3 years in engineering, ideally within the biotechnology or aseptic pharmaceutical sectors, or in Automated Inspection and/or Device Assembly environments. Proven project management experience is essential.
Strong mechanical skills with hands-on experience in a high-volume manufacturing setting are advantageous. Familiarity with GDP compliant environments and proficiency in MS Office, MS Project, Change Control, and Document Management Systems are required.
Demonstrated ability to work cross-functionally, delivering technical solutions and driving improvements is crucial. Strong leadership skills and experience in a collaborative team setting are necessary.
Excellent technical writing and communication skills, along with a data-driven approach to decision-making, are expected. The ability to meet tight deadlines in a fast-paced environment is essential.
This role requires a proactive approach, as you will need to develop the project roadmap independently. Each day presents new challenges, and you will be responsible for shaping the project from its inception.
Equipment Experience: The ideal candidate will have experience in commissioning equipment and troubleshooting issues, along with a solid understanding of critical equipment failures and root cause analysis in a GMP-controlled environment.
CompensationContract Role: Competitive hourly rate ranging from €45 to €57. This is a minimum 12-month contract with potential for extension. On-site presence is required more than 50% of the time, typically 3 to 4 days per week. Flexible working hours are available, with start times between 07:00 and 09:00 and finish times from 16:00 to 18:00. While project work may occasionally require unsociable hours, this is infrequent.
