Pharmaceutical or Biotech industry experience is STRONGLY preferred .
The ideal candidate will manage the Engineering group in development of project scope, design, and construction of projects within agreed cost and schedule parameters. Develop and manage to meet project scope, schedules and related project cost.
Manage Project Engineering contractor activities on a day to day basis.
Coordinate the activities of all related departments (Manufacturing, Technical Services, Product Development and Quality) to successfully complete all projects.
Provide engineering support to ongoing activities including process and productivity improvements.
Manage Engineering support in coordination of Technical Services, Product Development and Corporate Global engineering requirements for efficient product transfer, technology transfer and new product introduction.
Support the VP of Engineering in Engineering department management, Capital project development, project execution, project budget estimating, project budget control and Capital planning and budget reporting.
Supervisory Responsibilities :
This position will supervise other engineering personnel, contract engineering resources, construction contractor resources.
Bachelor’s degree in engineering, preferably in electrical, mechanical or chemical engineering
Advanced degree preferred
PPM degree preferred
OSD Manufacturing production experience is required
Good hands-on engineer with excellent people management skills.
Minimum of 15 years of project management related responsibilities in the pharmaceutical, biotech or related industries.
Proven record of successful multi-facility Engineering group management and implementation of global engineering standards.
Proven record of expertise in the purchase, installation, commissioning and qualification of oral solid dosage process equipment.
Proven record of expertise in the purchase, installation, commissioning and qualification of critical utilities (HVAC / CDA / USP Water / CF Steam) required in support of oral solid dosage production.
Proven experience with managing all aspects of proper material handling and employee safety.
Proven experience managing engineering design and construction of facilities compliant to current GMPs.
Proven knowledge of US FDA, EU, PICs regulatory compliance requirements.
Effective use of standard business software (Excel, Word, Access etc.)
Effective use of Microsoft project management software
Ability to communicate in a wide variety of communication styles and to become an effective team member with Production, Quality Assurance, Maintenance and Material Management personnel of all levels.
Effective presentations and report generation
Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
Physical Demands/Work Environment:
This position will be responsible for Project management across multiple sites in US and Asia. A reasonable amount of travel should be anticipated.
Occasionally exposed to moving mechanical parts and toxic or caustic chemicals. Noise level usually moderate, may occasionally be exposed to higher noise levels.
Ability to climb ladders
Occasionally lift and or move up to 50 pounds and push or pull up to 200 pounds.
Close vision and distance vision.
IMPAX Laboratories - 2 years ago