In this position, the ideal candidate will be the engineering resource responsible for independently applying advanced and diverse engineering principles to design and implement manufacturing system modifications, process improvements, maintenance projects, and capital projects associated with manufacturing operations and process utility systems. This individual will research, analyze information, and present interpretation of results for operational issues. The Sr. Process Engineer will also develop scope, lead the design and manage the implementation of capital projects of large scope and complexity. Key Responsibilities/Essential Functions
- Responsible for leading and driving the development of engineering specifications and standards for pharmaceutical manufacturing equipment and process utility systems.
- Identify root cause of failures on manufacturing and process utility systems and implement quality long term solutions.
- Demonstrate the use of problem solving skills requiring the application of engineering principles and calculations, scientific and creative methods in the development of hypotheses and approach to a large variety of technical challenges with moderate to large complexity and scope.
- Manage, coordinate and oversee development of project design documents. Select architecture and engineering firms to develop design packages. Lead project team reviews of designs/deliverables resulting in a documented progression of the project with stakeholder alignment.
- Prepare project estimates for all project related costs and manage the project against the established budget. Partner with procurement, finance and legal to prepare bid packages and constructioncontracts.
- Manage and administer contracts associated with assigned projects. Review, level and approve contractor bids. Respond to RFI’s, submittals and change requests. Inspect or direct the inspection of work to ensure conformance to design drawings, specifications, schedules, and safety regulations. Ensure contractors receive site orientation, safety training and that all state/local code requirements and building permit, inspection and project close-out processes are followed.
- Develop a prioritized site-wide manufacturing equipment and process utility strategy to guide the replacement or improvement of existing site equipment including strategies to reduce energy consumption in alignment with codes, current industry standards and regulatory trends.
- Evaluate manufacturing systems to identify inefficiencies in the manufacturing process and design operational changes or equipment modifications to improve the manufacturing and process utility system infrastructure. Include ROI analysis to support suggested opportunities/improvements.
- Serve as the site subject matter expert on pharmaceutical manufacturing process equipment and utilities operations, design standards and technology to meet evolving pharmaceutical industry standards. This includes radiopharmaceutical manufacturing process equipment with a focus on providing integrated reliability with allowances for appropriate maintenance while in radiological service.
- Work closely with manufacturing, process development, facilities, quality assurance and other departments in developing requirements and recommendations for small to large system/facility modifications.
- Works closely with Environmental Health and Safety, Facilities, Manufacturing, Finance, Procurement, and Quality Staff to realize organizational objectives.
- Achieve high customer satisfaction through effective communication of both technical and non-technical topics with all levels of the organization both verbally and in writing.
- Exhibit project and technical leadership, self-confidence and effective decision-making throughout each project and consistently deliver projects that meet all stakeholder requirements and are fully commissioned, qualified and ready for start-up/occupancy.
- Provide support in the development, review and maintenance of operational SOPs and predictive/preventive maintenance job plans.
- Take appropriate actions to diagnose and correct manufacturing equipment and process utility engineering, operating and maintenance issues as they occur in partnership with maintenance, manufacturing, and quality departments.
- Responsible for supporting departmental vision that will provide for continuous improvement in all aspects of the organization.
- A Bachelors’ Degree in an engineering field.
- Minimum of 7 years’ experience with Pharmaceutical/Biotech processes and systems design, engineering, commissioning, documentation, validation, maintenance, change control, and performance benchmarking of systems in a pharmaceutical / life sciences environment.
- Strong understanding of Quality Systems. Solid understanding of cGMPs. Able to apply guidance documentation to implement systems aligned with current industry trends and establish best practices.
- Demonstrated skills in basic technical report writing: Engineering studies, user requirement specifications, commissioning documents, etc.
- Proficiency in manufacturing equipment and process utility systems design, layouts, and trade coordination.
- Excellent leadership, organizational and time management skills.
- Excellent oral & written communication skills. Ability to develop technical presentation materials and present.
- Demonstrated working knowledge of MS Office, AutoCad, and process flow modeling software systems required.
- Demonstrated expertise in the use of MS Project to plan, track and manage complex project schedules and budgets.
- This individual should be a self starter with strong leadership, interpersonal, organizational and technical skills, with the capability to work both independently and in a team environment. Strong analytical and communications skills are critical. .
- Affiliations with relevant industry associations, such as ISPE, PDA, etc.