I: Job Summary
Support/lead project and other activities on campus by offering technical inputs in their area of expertise. Represent engineering / company at internal or external meetings. Provide leadership, mentoring and training to other engineers / personnel on campus.
- Provide depth and breadth of expertise in engineering and technical support on process development and technical areas.
- Apply in-depth skill and broad knowledge of business to address complex problems and non-standard situations
- Represents EBS to external customers, at conferences and/or organizations such as ISPE, PDA or ASME
- Oversee the generation of developmental of white paper and technical information for presentation to FDA, EU or similar inspection agencies.
- Mentor and/or supervise otherinternal engineers and scientific staff as necessary
- Responsible for coordination of all technical activities on assigned projects.
- Ability to recognize and solve technical problems
- Use professional concepts to contribute to the development of Emergent concepts and principles and to achieve objectives in creative and effective ways
- Provide strategic vision and leadership while approaching projects and ensure that the project aligns with long term vision
- Coordinates the review and checking of engineering deliverables
- Coordinates the efforts of engineering support groups and external resources such as vendors, consultants and contractors
- Prepare engineering calculations and analysis related to process design and equipment selections.
- Solves unique and complex problems that have broad impact on the business.
- Report on planning and progress of activities to senior management
- Provides technical leadership to Formulation and/or Analytical Method Development and testing for biopharmaceutical products.
- Maintains expertise in relevant methodology, scientific literature and familiarity with regulatory/ICH/pharmacopeia requirements for Biopharmaceuticals.
- Expands current knowledge of the field and regularly contributes to expansion of functional area capabilities.
- Interacts with contract, corporate, and governmental agency representatives and auditors.
- Possess broad knowledge of quality and regulatory requirements such as USP, ICH, GLP/cGMP
The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
III: Education, Experience & Skills
- Bachelors of Science degree in an Engineering discipline
- Engineeringdegree in, mechanical, chemical, biochemical, electrical, or civil disciplines
- Training or exposure to project management
- 12years of engineering and/or project management experiencerequired in an biotechnology or pharmaceutical industrial setting.
- Detailed knowledge of facilities, systems, and infrastructure within an industrial setting.
- Excellent leadership, presentation, computer, and communication skills.
- Must be able to provide clear direction while motivating teams.
- Must lead by example through strong work ethics and high standards.
- Desire to promote personal development.
- Advanced training in engineering, business or project management
- Member of PMI, ISPE, ASME, or AICHE
- EIT, PE, CAPM, PMP or LEED certification
- Familiar with pharmaceutical industry guidelines such as ISPE Baseline Guides, ISO and ASME BPE
- Experience in a pharmaceutical, biopharmaceutical, and consumer products process company or food industry.
- Experience in a federally regulated industry.
- Possesses depth and breadth of expertise in engineering and related fields.
- Experience and understanding of biological processes.
- Experience in construction management.
- Must possess the ability to influence supporting departments.
- Must be able to receive constructive feedback and adapt to change within a dynamic environment.
- Must be tenacious while maintaining integrity and self-awareness.
- Must be able to adapt to change viewing obstacles as opportunities.
- Knowledge of CAD software and equipment.
- Working knowledge of CSI divisions.
- Working knowledge of SAP.
- Familiarity with FDA regulations relating to biologic and drug products.
- Familiarity with FDA current Good Manufacturing Practices.
- Expert knowledge of engineering principles and concepts.
- Industry recognized leader in field with sustained performance and accomplishment.
Req Id 19545