Biotech à United States

The Maintenance Engineer is responsible for GMP and non-GMP utilities and equipment engineering at the Milton Park facility (UK). The individual will oversee external vendors and contractors to ensure maintenance and calibration activities are performed, documented, reviewed and approved in the computerised maintenance management system (CMMS). Provide routine engineering support for utilities and laboratory equipment, as well as project engineering and validation support. This position will include equipment ownership responsibilities for a select portion of equipment/utility portfolio serving as subject matter expert leading investigations relating to deviations in partnership with Quality Control (QC), Quality (QA) and other departments.

Key responsibilities:

• Equipment ownership responsibility for utilities, facility owned equipment and systems, which includes troubleshooting equipment to determine root cause of failure modes, owning corrective and preventative actions and associated change controls, providing input into preventative maintenance plans, assessing change controls, and continuous improvement initiatives.
• Collaborate with cross-functional teams and/or lead investigations into equipment issues including technical writing of required quality documentation.
• Oversee outside vendors and contractors to ensure work is performed and documented in compliance with cGMP policies and procedures.
• Review and approve vendor documentation for accuracy and compliance in the CMMS system.
• Ensure that all work is performed in accordance with Standard Operating Procedures (SOPs), Current Good Manufacturing Practices (cGMP), safety procedures, quality standards, EH&S guidelines, other regulatory agency standards, and good maintenance practices.
• Promote safety within the workplace by following site safety procedures, ensuring contractors are following safety requirements, performing proactive safety assessments, and fostering a safe work culture.

Other responsibilities:

• Assist with internal and regulatory agency audits / inspections serving as SME in discussions with internal and external auditors.
• Support equipment validation and maintenance activities to ensure utilities and equipment remain compliant with required procedures and regulations.
• Ensure training is kept in GMP compliant state.

Educational requirements:

• BSC equivalent minimum requirement in a related field or work experience in GMP environment

Experience and skill requirement:

• Minimum 2 years experience working in the biotech pharmaceutical environment preferred.
• Familiarity with Computerised Maintenance Management System (CMMS) to record maintenance work activities.
• cGMP documentation - Facilities documentation (work orders, equipment files, calibrations, developing SOPs) and QA systems (CAPAs, deviations, change controls)
• Knowledge of equipment Qualification and Validation requirements
• Working knowledge of Microsoft Office (Word, Excel, Outlook, etc.)
• Excellent communication and interpersonal skills are required. Attention to detail, flexibility and technical writing skills are also important skills for this position.
• Ability to work independently or in a team environment as well as being self-motivated and showing initiative.

Location:

• This position is based in ourMilton Park location and typically has a 5-day on-site expectation.