Project Engineer

Project Engineer.  The Project Engineer will provide technical and engineering expertise to establish and maintain efficient manufacturing and packaging operations. The Project Engineer will manage technology, process development, process validation and process improvement. The Project Engineer will provide engineering and project management expertise across all functional areas as needed; including pharmaceutical processing, facilities, manufacturing and packaging equipment, operations and quality. The Project Engineer will focus on process improvement.

Other responsibilities include:

• Identify and implement cost reduction initiatives
• Conduct manufacturing investigations
• Prepare validation documentation (protocol and reports)
• Ensuring manufacturing/packaging instructions and Standard Operating Procedures are properly and factually written and up to date for new equipment and processes
• Management/removal of manufacturing constraints
• Assist with corrective and preventative investigations
• Liaising closely and maintaining strong relationships with Production Team Leaders
• Checking and auto rising documentation and reporting as required
• Making sound technical decisions in the Production Manager’s absence
• Assist with process/equipment troubleshooting
• Increase productivity of labor and plant by: supporting the monitoring of actual performance against budget/target data, identifying problem areas and initiating corrective action, continuously improving all aspects of production operations, ultimately leading to a world’s best practice plant. Ensuring sufficient resources and systems are developed and in place to meet business objectives.
• Manager and control capital expenditure within agreed budgets and report on any variances
• Management of plant, equipment and instrumentation installations
• Scope new facility modifications and equipment to meet business needs (process/quality improvements) and GMP compliance
• Serve as the technical liaison on Technical Transfer projects responsible for ensuring a robust transfer and start-up according to plan and all regulatory requirements.
• Conduct manufacturing investigations associated with process and equipment
• Non-conformance reports are addressed in a timely manner
• Projects and activates reported on a monthly basis
• Checking and authorizing documentation and reporting as required
• Providing technical support to manufacturing, packaging, QC, QA, HSE as needed
• Bet he engineering/technical subject matter expert for processing equipment, packaging equipment and automation

Qualifications include:

• Bachelor’s degree in mechanical, automation or chemical engineering with minimum 5+ year’s experience preferably in a pharmaceutical/life science manufacturing environment
• Exceptional project management skills
• Intimate with pharmaceutical processes and equipment
• Proven cost reduction/process improvement skills in processing, packaging, and labor utilization
• Knowledge of GMP and FDA manufacturing regulations
• Strong numeracy skills
• Ability to analyzes and interpret data
• Strong written and oral communication skills
• Skill in examining and re-engineering operations and procedures, formulating policy, and developing and implementing new strategies and procedures
• Project justification methodologies
• Computer literacy-ERP systems and Microsoft packages
• Knowledge of latest production technologies, including constraint management and Lean manufacturing
• Knowledge of quality management systems
• Ability to manage resources in order to meet changing priorities
• Detail oriented
• Commercially strong
• Ability to “sell” ideas internally
• Demonstrated ability to lead, coach and support and be a mentor and positive role model
• Ability to conceptualize plans and technical solutions
• Excellent time management skills
• Objectivity and sound judgement
• Good conflict resolution skills
• Respect for confidentially; ability to deal with sensitive issues
• Initiative, flexibility, innovativeness
• Commitment to provision of high quality client service
• Experience and commitment in working as part of a team as well as individually
• Proactive, committed to achieving challenging objectives, forward thinking and success driven
• Sense of humor
• Makes timely decisions
• Innovate, creative, takes initiative
• Science-based thinking and problems solving
• Thinks and works analytically
• Makes high quality decisions that takes into account both short and long term considerations
• Responds to both internal and external customer’s needs, questions and concerns in an accurate, effective and timely manner
• Demonstrates for the care and safety of others
• Ability to understand the Bigger Picture
• Helps provide a clear result-focused sense of direction for the team and co-workers to support the department’s and companies vision
• Understands the impact of the job/department on the rest of the team
• Lead and manage to ensure a consultative team based and performance oriented culture
• Promote the strategic goals and objectives of the organization and develop a positive culture

To be immediately considered for this animal health job opportunity, please apply here: