The Engineering Manager will have a vast understanding of engineering, engineering management, manufacturing, quality assurance, product design and process development in pharmaceutical and medical device manufacturing and will be responsible for all technical engineering tasks for execution of new product development projects, and major CAPEX Site Project approval and execution.

Interacts closely with Project Management and MS&T teams for clinical and development projects to ensure the execution of projects are performed in a timely manner and on schedule.  Ensures the Process Engineers provide updates and supporting information to Project Management to  ensure project status and critical information is accurate and provided in a timely manner.

Will ensure technical and engineering proficiency of new product and material technical development, product efficacy and safety validation, biocompatibility testing, preparation of IDE, IND, PMA and NDA technical sections, initiating and developing new technical and product release process.

Must have very strong technical credentials and also have the ability to manage and develop the people and functions that are part of the Engineering department.  The Engineering Manager must also work closely with other departments on site initiatives for facility, equipment acquisition, site modifications, and qualifications.

Responsibilities

1. Interface with Project Management and MS&T teams to direct the execution of new products with the Process Engineers .
2. Meet agreed upon budget and ensure compliance goals are met.
3. Work closely with engineers executing development and clinical project execution in Manufacturing to provide guidance and assurance that project timelines are met.
4. Work closely with Manufacturing, Materials and Quality Assurance to execute new customer development projects in the manufacturing system while meeting critical customer timelines and cost targets.
5. Provide leadership and oversight his/her direct reports in the engineering team
6. Provide technical support to Maintenance, Facilities and Calibration management.
7. Lead major CAPEX process or equipment projects as required.  Coordinate required qualifications and validations.
8. Provide technical support to the manufacturing group as required.
9. Fulfill responsibilities as a member of the DCR, Deviation and CAPA team.
10. Identify potential manufacturing process or product improvements and implement efficient manufacturing methods to produce quality products.
11. Oversee design and installation of production tooling and equipment. Direct launch of new products and processes at the production floor level execution.
12. Provide technical support for evaluating and resolving CAPA’s.
13. Responsible for department budgeting, equipment purchases, and project planning.
14. Evaluates testing and manufacturing equipment in order to purchase or to make recommendations for purchase of equipment to be used in Manufacturing.
15. Lead the engineering professionals on product development, process validation and design control.

1. Stay abreast of current and newly emerging technologies to ensure that appropriate manufacturing techniques are utilized to manufacture high volume, high yield and high value products in aseptic operations.
2. Any and all other duties as assigned by immediate supervisor.

Required Knowledge, Skills and Abilities

• Ability to function well in a team environment.
• Requires extensive interfacing with manufacturers of equipment and vendors of diverse educational backgrounds.
• Must possess excellent oral and written communication skills.
• Must interface well cross functionally.
• Strong well-rounded engineering and project management experience.
• Superior analytical and computer skills.
• Capable of using good reason and judgment to make and defend recommendations.
• Proficient in computer skills, with Windows, Word, Excel, AutoCAD 14, Solid Works, Microsoft Project etc.

Required Education and Experience

• Bachelor of Science Degree in Engineering. Master's Degree preferred
• 10 years engineering experience in manufacturing/product development environment in medical/pharmaceutical or similar industries
• 3 or more years’ experience in managing an engineering team
• Experience in Aseptic Processing is an advantage
• Further preferred qualifications: PMP, MBA, Lean Six Sigma Green Belt