Position Details

Responsibilities:

• Lead & manage new process & improvement projects from conception to completion.Support the generation & periodic assessment of key deliverables including system impact assessments, criticality assessments, risk assessments, maintenance & calibration activities 
• Generate & analyze data to monitor process/equipment performance & identify areas for improvement.Ensure processes comply with GMP & other regulatory requirements.Review& approve contractor MSRA’s, Process Designs, Engineering drawings. 
• Ensure compliance with company Safety, Environmental & Quality.
• Assist in investigations & root cause analysis of equipment, utility & control system anomalies, & safety incidents.
• Ensure value engineering, constructability reviews & processes are effectively utilized to minimize capital expenditures & maximize value
• Initiate, lead & execute CI activities in safety, energy, waste elimination across functional areas (production, utilities, logistics, maintenance etc) using lean manufacturing principles. 
•    Review & approve documentation, ensuring technical accuracy & adherence to cGMP.
•    Confirm all vendor documentation executions are compliant with GxP practices & the executed documentation is acceptable.
•    Liaise with the various stakeholders to ensure clear communication between all parties; lead and participate in multi discipline cross-functional teams.
•    Review and contribute to deliverables such as technical requirement specifications and vendor turnover documentation.
•    Preparation for & presentation of systems during internal & external regulatory audits; closure of open audit findings in timely manner 
•    Generate cost estimates for scopes of work & manage project spend to budget.
•    Identify key risks & identify action plans to mitigate risk. 
•    Provide technical support to production & maintenance & troubleshoot process-related issues.
•    Develop & deliver training programs for new processes & equipment.
•    Mentor maintenance engineers and support their professional development.

Competencies:

•    Understanding of industry standards & best practices for a science & risk-based approach to qualification of systems, equipment, utilities, and/or facilities
•    Experience with quality risk management
•    Knowledge of process equipment, utilities, operations, & engineering principles within a Biopharma environment 
•    Must possess problem-solving & critical thinking skills.
•    Motivated, self-starter with strong mechanical aptitude
•    Ability to work both independently & collaboratively across multiple disciplines in a fast-paced & dynamic environment.
•    Excellent interpersonal, team, & communication skills are a must
•    High level oral & written communication skills are a must
•    Possess effective task/time management organizational skills

Essential Education and Experience:
•    Bachelor’s degree in engineering science or related program with the following years in relevant experience:
•    5+ years’ experience of working within Engineering in a regulated GMP/Biotech environment.
•    Excellent problem-solving skills & attention to detail.

Other Skills:
•    Experience with operation, maintenance & troubleshooting process equipment such as Lyophilisers, autoclaves, tablet presses, blister machines, fermenters & clean utilities
•    Understanding of PLC/Robotics & Vision systems, 2/3D CAD skills
•    Project Management training
•    Use of Lean 6Sigma principles, including SMED, DMAIC & Green Belt