Sr Principal Engineer
The position will support the development of a new, state-of-the-art plasma fractionation facility that will bring Baxter additional capacity for testing, purification, and fill and finish for its biologic medications.
Displays standard engineering principles to resolve difficult problems, from conception to final design with team input. Plans, schedules and leads project assignments in the evaluation, selection and adaptation of various engineering techniques, procedures and criteria with minimal guidance. The candidate is responsible for developing, evaluating and implementing cost-effective equipment, facility and utility engineering solutions for a greenfield manufacturing facility in a fast-paced cGMP, biotechnology environment. This includes all phases of the project including conception, developing justification, presenting to management, preparation of capital impact analysis, budget management, project timeline creation and management, detailed design, creating specifications (Design/Functional/System) and vendor/contractor scopes-of-work (RFQs/RFPs), competitive bidding, placing purchase orders, contractor and consultant supervision, creating and executing change control documentation, performing factory and site acceptance tests (FATs/SATs), installation, commissioning, debugging, optimization, supporting Validation and training maintenance and manufacturing personnel.
The candidate must possess the interpersonal skills required to work well in a cross-functional team-based environment. The candidate should possess excellent written and verbal communication skills, have a positive attitude, be self-starting, detail oriented and able to work independently with minimal supervision.
Essential Duties and Responsibilities
The Hygienic Engineer will also be on-call at all times to respond to plant-wide emergencies and manufacturing needs.
- Work independently with minimal supervision to execute all facets of projects, Expected to make suggestions on improvements based on supporting data, technical knowledge, engineering principles and current industry practices.
- Define project scopes, prepare cost estimates, and provide justification for major capital budget items.
- Manage and control the spending of approved project funds.
- Create an initial project timeline and manage the project schedule.
- Lead the planning and execution of small and medium sized capital projects related to production and/or facility requirements.
- Support the planning and execution of large sized capital projects related to manufacturing and/or facility requirements.
- Manage small to medium sized components of the green field project with minimal assistance.
- .Able to participate and make suggestions for capital planning, spending and tracking.
- Drive projects to completion and meet timeline and budget objectives.
- Investigate and analyze voice of customer concerns and suggest and implement design improvements.
- Supervise contractors, technicians and consultants on projects and activities.
- Supervise more junior level engineering personnel on projects and activities.
- Create or update written Standard Operating Procedures (SOPs) related to project assignments.
- Create or update technical specifications (Design/Functional/System) related to project assignments.
- Ensure all mandatory training requirements are met, including annual EHS training, GMP refresher training, and any applicable training requirements.
- Demonstrate continuous improvement with respect to increasing job knowledge and proficiency related to engineering in the biopharmaceutical industry, as well as technical understanding/problem solving capability.
- Stay current with the biopharmaceutical industry best practices and technologies.
- Maintain a positive, professional and customer-oriented attitude at all times.
- Challenge the status quo, as appropriate, to ensure all viable options are discussed and evaluated.
- May perform other duties as assigned.
- Must have a demonstrated track record of successfully executing engineering projects, and supporting facility issues, in a FDA-regulated manufacturing environment. Green field experience is desirable.
- Possess knowledge of core principles in various engineering disciplines including manufacturing (ie. cell culture/fractionation//purification/aseptic filling/packaging/cGMP facility design), support systems (WFI/RO/clean steam/compressed gases/HVAC) and facility design.
- Must have excellent organizational, verbal and written communication skills; Able to efficiently communicate with cross- functional teams and management on recommended course of action, with minimal assistance.
- Must have proficient computer skills and be experienced using MS Office software (Word, Excel and PowerPoint) and MS Project.
- Must have the ability to effectively lead Engineering projects, coordinate contractors, and drive results. Direct experience with manufacturing operations and biotechnology processes is strongly preferred.
- Must possess basic knowledge of core principles in various engineering disciplines (fluid mechanics, heat transfer, thermodynamics etc…), as well as be experienced applying project management methodology.
- Must have good interpersonal skills and be able to work effectively and efficiently in a team-based environment.
- Knowledge of programmable logic controllers, instrumentation and controls highly desirable.
- Has the ability to prioritize multiple tasks and work on multiple projects simultaneously.
- Must be a self-starter, detail oriented and able to work independently with minimal supervision.
- Must embrace working in a fast-paced, team-oriented, cross-functional environment.
Education and/or experience
B.S. degree required in an Engineering discipline with the preference being Chemical, Mechanical or Biomedical Engineering, with 10+ years of experience in an engineering role within the pharmaceutical, biotechnology or related cGMP industry.
A minimum of 3 years of experience executing capital projects is preferred.
Must have experience with equipment sanitary design principles and materials of construction used in the biopharmaceutical industry.
Should also be knowledgeable with respect to one or more the following: aseptic processing and filling, lyophilization, capping, ultrafiltration, chromatography, centrifugation, filter press and other filtration systems, cGMP facility design (cleanrooms, ISO classes, HVAC), utility systems common to the biopharmacutical industry (e.g., WFI, RO water, compressed gases and clean steam), clean-in-place (CIP) and steam-in-place (SIP) equipment and cycles, air-handling-units, autoclaves, clean room design and operating principles .
Must be familiar with cGMPs, Good Engineering Practices, as well as FDA and EU regulations. Basic knowledge of programmable logic controllers (PLCs), DCS systems and instrumentation (e.g., flow, pressure, temperature, level, conductivity, UV) and controls is desirable.
Knowledge of support equipment such as air-handling units, solvent recovery, autoclaves and parts washers is also desirable.