Site Engineering Lead

​JOB OVERVIEW

• Maintaining all site facilities in best conditions and within the framework of Good Manufacturing Practice (GMP) & EHS requirement.
• Manage facility and utility operations in the correct manner to support daily laboratory operation and general business activities.
• Responsible for initiating and updating site field manual, SOPs as required
• Develop maintenance strategy and best practices to achieve maintenance deliveries & KPIs
• Develop proactive partnership with customer
• Ensure required safety, quality, compliance, service and performance standards are met.
• Drive continuous improvement and innovation
• Apply risk-based approach to improve maintenance program
• Manage activities within budget; assess solutions and practices to ensure cost-effectiveness
• To coordinate field activities in the execution of daily routine facilities and maintenance work.
• Planning and coordinating vendor site servicing activities.
• Executing and closing of Work Orders as per schedule.
• Able to perform troubleshooting of general building M&E equipment
• Perform regular plan preventive maintenance tasks to ensure asset integrity and free from defects.
• Familiar with instrument calibration program

Key Accountabilities

Safety

• Act as a visible safety leader and coach proactive safety behaviours in the team; lead by example to help ensure that positive and transparent EHS culture exists within the JLL team on the site
• Ensure required Regulatory, JLL and Client safety standards are met for all aspects of work delivered by team (staff or vendor)
• Ensure EHS relevant devices are in place (PPE, LOTO devices…)
• Proactively ensure any EHS near misses, incidents or best practices are reported and shared
• Support accident and injury investigation
• Ensure risk assessments and method statements are in place for all work (JLL staff or vendor). Proactively identify safety hazards and risks at the Client location and mitigate in accordance with best safety practice
• Establish regular EHS self-inspection routine and make action plan accordingly
• Ensure all regulatory/compulsory EHS training is completed and training records are documented in a timely manner for audit readiness.

Quality Management System

• Ensuring team’s adherence to governing SOPs and quality policies (JLL or Client) where relevant
• Lead by example to help ensure that positive and transparent quality culture exists within the JLL team on the site and that quality risk management is embedded into decision making
• Proactively ensure any quality issues, incidents or best practices are reported and shared
• Ensure timely completion of all quality training by the team
• Support GMP incident root cause investigations and CAPA creation / completion as necessary
• Participate in JLL self-audits; assist in Regulator and customer audits as required
• Participate in generation and review of the following documents if applicable to JLL scope of work:
• Change control
• Deviation investigation & management; root cause investigations, equipment failure investigations, CAPAs generation and implementation
• SOPs (periodic review)
• Qualification and validation protocols
• Quality Notifications based on equipment out of tolerance conditions
• Any other GxP documents according to governing procedures
• Ensure all infrastructure and compliance documentation for the systems is up-to-date (e.g. maintenance logs, drawings and single-line diagrams)
• Spare parts management (GMP spare parts identification is needed)
• Ensure that service quality levels and relevant KPIs are met
• Ensure all activities are documented in time achieved periodically
• Be vigilant to ensure subcontractors understand compliance requirements such as GxP requirements and Change Control

Approval Roles

• Review internal or external change request
• Prepare or review GMP/EHS relevant incident/accident report
• Review services contracts and Purchase Order
• Prepare or review resource added or staff resignation
• Approvals for similar role of Site Lead as his deputy in his absence from work
• JLL internal DOA approvals (procurement, financial, HR, etc.)

Business and client engagement

• Develop healthy customer relationships through proactive engagement.
• Ensure correct customer focus is in place for all activities undertaken by function
• Proactive communications with client and provide solutions to client’s base onsite situations
• Periodically meeting with client and provide feedback about daily operation and maintenance

Compliance

• Act as visible leader for all compliance related issues, reinforcing the Code of Ethics and JLL values in every interaction
• Ensure all team members follow ABAC policy
• Ensure required Regulatory, JLL and Client policies, standards & procedures and are met for all aspects of work delivered by team (staff and vendor)
• Ensure and encourage transparent reporting of compliance issues or potential compliance issues
• Complete all mandatory JLL and Client compliance training; ensure team also does the same

Strategy

• Identify GMP relevant activities and provide audit support to site team
• Ensure all activities to match client’s requirements defined in Scope Of Work/ Operational Responsibility Matrix.
• Periodically review CM work orders and update PM activities/plan accordingly

Discipline Leadership

• Act as visible leader, instilling the correct level of professionalism and customer focus
• Proactively complete or lead any work in support of meeting both Client needs and JLL’s contractual requirements.
• Identify and implement continuous improvement opportunities
• Hire, supervise and manage site staff
• Ensure robust personal development and performance management is in place for staff

Engineering Delivery

• Ensure the JLL facility team is delivering in accordance with the Client business need and that services are meeting required standards
• Maintenance/calibration/spare parts strategy and plan preparation and get approval from client
• Develop tools/standards management procedure
• Recruit, select, train, and appraise performance
• Optimize business processes, initiate improvements, cost-saving activities to increased productivity / work efficiency to drive Client value
• Deliver within appropriate budget constraints
• Develop and oversee capability of the maintenance and facility team across the site
• Ensure operations in line with Client and JLL policies and processes
• Training matrix preparation and ensure team members get trainings accordingly
• Ensure Work Orders review and update PM program accordingly for best practices
• Periodically report preparation as required (KPI, OT, cost, EHS, unexpected shutdown, quality relevant, spare parts, incident/accident, next action…)

Budgets / financial / commercial

• Negotiate budgets with stakeholders for areas of accountability and deliver services within budgets
• Certify vendor work as complete, review vendor invoices accuracy.
• Develop technical scope of work for work requiring vendor support; work with Procurement stakeholders to ensure appropriate contract or purchase orders are in place
• JLL internal DOA approvals (procurement, financial, HR, etc.)
• Compile data and work with Finance team for JLL budget forecast

KEY WORKING RELATIONSHIPS

Internal (within site)

External (to site)

JLL

• Site Lead/ Account manager
• Site maintenance / utility team member
• Other engineering team members
• Third Party Service Providers

Client

• Engineering / Technical Services
• Equipment/System/Area Owner
• Quality Assurance
• End Users / Stakeholders
• Regulator representatives / Auditor
• Client Corporate Business Partner
• Client Customer

EDUCATION, QUALIFICATION, EXPERIENCE & CAPABILITY

Essential

Desirable

Education / Qualification

• Bachelor degree or above, engineering or relevant discipline
• Experience in GMP and GEP work environment

Experience

• 5-8 years of experience in engineering operations and facilities/process equipment maintenance
• 5+ years facilities/equipment maintenance in GxP environment
• 5+ years team management experience
• Client audits, regulator audits (FDA, cFAD…)
• Capital project management
• Engineering/Maintenance experience in GMP environment / facility
• International company working experience is preferred

Knowledge

• Local regulations requirements for site facilities management
• EHS relevant procedures
• Detailed requirements for GMP utilities like CU, HVAC, EMS and other GMP utilities etc.
• GxP quality system requirements (deviation, change control, CAPA, risk management, documentation management…)
• GMP / non-GMP facilities/equipment maintenance/calibration requirements (PM, PdM, CM, EM…)
• Clients and vendor management
• KPI management skills
• People development and motivation knowledge
• Life Science / Pharma / Biopharma process knowledge
• Familiar with engineering design standards
• Knowledge of reading drawings
• Maintenance excellence knowledge (FMEA, RCA…)
• GEP knowledge (ASME…)
• Lean 6σ knowledge
• EHS Knowledge
• Familiar with Instrument Calibration program

Other Capabilities

• Good English skills in reading, writing, listening and speaking
• Ability to train and coach other people to match working requirements
• Continuously improvement
• Targets driven
• Troubleshooting and analysis
• CMMS / CMS operation
• Automation (BMS, EMS, SCADA…)
• CMS operation