Engineering Manager

Engineering Manager

Requirements

• BS degree in engineering subject area with 5-7 years of manufacturing engineering experience or equivalent manufacturing experience
• 5+ years of demonstrated effective supervisory skills
• 5+ years engineering/manufacturing experience
• Must have demonstrated interpersonal and leadership skills with the ability to interface well with personnel of all levels
• Must have ability to understand and follow cGMPs, FDA guidelines, and other regulatory guidelines applicable to the medical/pharmaceutical industry
• Demonstrated ability to manage multiple priorities in a manufacturing setting and prioritize responsibilities of self and direct reports appropriately
• Must be able to supervise multiple groups/departments
• Able to work and facilitate a team-oriented environment
• Possess problem solving skills using cause mapping and A3’s
• Have organizational and administrative skills
• Strong communication skills (both verbal and written)
• The ability to analyze and interpret scientific and statistical data
• Must have strong skills for operation and controls of manufacturing equipment and processes
• Able to work in controlled environment requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body

Responsibilities

• Responsible for engineering and drafting departments
• Supervise, lead, and coordinate engineering activities directly or through direct reporting supervisors
• Provide project engineering/process engineering resources to support facility manufacturing operations
• Integral part of the manufacturing technical response plan for equipment maintenance/reliability
• Drive performance with employees by providing a positive and equitable work environment emphasizing respect, responsiveness, and results
• Support and maintain all environmental, health and safety programs, as well as all other plant activities to ensure a robust safety culture and environmental regulatory compliance
• Facilitate and verify appropriate training for all team members (including but not limited to safety, cGMPs, job skills, JIB’s, etc.)
• Inspect, monitor, assess, and assure the facility and manufacturing equipment remains cGMP compliant and in a constant state of audit readiness
• Ensure assigned projects and work (i.e. corrective actions, exception reports, meeting action items, etc.) are completed per the commitment date
• Analyze, propose, and correct long-term solutions to existing and repeating problems
• Drive the procurement and installation of new equipment
• Coordinate, oversee, and manage contractors as needed to meet the responsibilities of the department
• Support and encourage all plant activities, i.e. VIP, TPM, 6-S, Lean, QOS teams, plant growth and development
• Must perform all other duties and responsibilities as determined by supervision/management

Preferred Qualifications

• FDA/cGMP experience preferred
• Microsoft Office and Microsoft Project experience is preferred
• Project Management experience is preferred
• Six Sigma Master Black Belt Certification or industry standard equivalent is preferred
• Lean Manufacturing skills and experience is preferred