No Deviation is a provider of patient-centric solutions for the pharmaceutical industry, and we are currently seeking individuals who are passionate about joining our team. Our areas of expertise include engineering consultancy, Commissioning Qualification Validation (CQV), as well as Quality, Compliance, and Regulatory services.
We strongly uphold our core values of Empathy, Integrity, and Transparency, and we strive to create a collaborative, innovative, and inclusive work environment that fosters personal growth and development.
We are looking for a talented Project Engineer with a strong background in Civil, Structural, and Architectural (CSA) disciplines, particularly in cleanroom construction for pharmaceutical or life sciences projects. The ideal candidate will have extensive knowledge of GMP (Good Manufacturing Practice) standards and will be instrumental in the design, planning, and execution of cleanroom facilities. This role involves collaborating with multidisciplinary teams to ensure adherence to project timelines, quality standards, and regulatory compliance.
By joining our team, you will have the opportunity to make a meaningful impact in the pharmaceutical industry while advancing your career.
Scope & Responsibilities:
- Oversee and manage the civil, structural, and architectural aspects of cleanroom construction projects, ensuring all work complies with GMP standards.
- Collaborate with cross-functional teams, including mechanical, electrical, and validation engineers, to ensure seamless integration of systems within the cleanroom environment.
- Review and approve CSA designs, ensuring they meet the technical specifications, safety requirements, and regulatory guidelines for cleanroom construction.
- Lead the site supervision and management of contractors involved in CSA works, ensuring all activities are completed according to the approved project schedule and budget.
- Conduct regular site inspections to ensure construction adheres to GMP and cleanroom standards, addressing any non-compliance issues.
- Prepare and maintain detailed project documentation, including progress reports, technical drawings, and compliance documentation.
- Coordinate with quality assurance teams to ensure cleanroom construction meets regulatory and validation requirements.
- Manage and mitigate project risks, ensuring timely resolution of any issues that arise during the construction phase.
- Provide technical support and advice on CSA matters throughout the project lifecycle, including design, construction, commissioning, and handover.
- Knowledge of HVAC systems for cleanrooms and their interaction with CSA elements.
Qualifications:
- Bachelor’s degree in civil engineering, Structural Engineering, Architecture, or a related field.
- 5+ years of experience in CSA project management, with specific experience in cleanroom construction within the pharmaceutical or life sciences sectors.
- In-depth knowledge of GMP regulations and cleanroom standards (ISO 14644, EU GMP Annex 1, etc.).
- Proven experience in managing CSA works in compliance with regulatory standards for cleanroom environments.
- Strong understanding of construction methodologies and building codes relevant to pharmaceutical facilities.
- Project management skills with the ability to handle multiple tasks, priorities, and deadlines.
- Excellent communication and leadership skills for coordinating with contractors, suppliers, and cross-functional teams.
- Experience with BIM (Building Information Modeling) or other construction management software.
- PMP certification or similar project management certification is a plus.
