Position Details

Responsibilities:

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

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

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