Principal Process Engineer


Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Principal Process Engineer in our Brooklyn Park, Minnesota office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Principal Process Engineer working on the Engineering team, you will be empowered to act as engineering lead for a specific process area and manage complex projects, and a typical day will include:

POSITION OBJECTIVES:
•Serve as the engineering lead for a specific process area (cell culture, harvest, purification, clean-in-place, or clean/facility utilities equipment) ensuring systems remain in a qualified state
•Responsible for system operational reliability and performance monitoring
•Act as technical owner for system lifecycle. This will include design and installation of equipment, qualification, support of ongoing operations, deviation resolution, maintenance, and decommissioning
•Lead large complex technology transfers and site improvement projects
•Lead development of site staff related to procedural and technical matters. Act as SME for process, facility, and automation systems.

POSITION ACCOUNTABILITIES:
•Develop engineering deliverables including: Process Flow Diagrams, P&IDs, System Specifications, and Functional Specifications,
•Implement system modifications under cGMP change control
•Develop and execute Factory Acceptance Tests (FAT), commissioning protocols, and qualification protocols.
•Develop robust calibration and preventative maintenance plans
•Lead investigations into system deviations and implement corrective actions and preventative actions
•Develop, evaluate, and implement engineering solutions to complex problems
•Stay current with biopharmaceutical industry best practices and technologies
•Participate and make suggestions for capital planning, spending, and tracking.
•Serve as Project manager and/or Technical Lead for capital projects of all sizes (>$10M). Role requires developing or managing: project justification, budget and schedule management, vendor/contractor scopes-of-work, capital impact analysis, resource planning, contractor and consultant supervision, and serve as the technical lead
•Lead Development and implementation of programs related to system qualification, asset management, project execution and GEPs
•Provide technical mentoring to junior level engineers and resource and scope prioritization on project basis.
•Interface with various roles and departments to accomplish project goals
•Work independently with minimal supervision and provide technical leadership and instructions to less experienced team members
•Requires participation in 24/7 on-call support rotation with other automation and process engineering personnel

EXPERIENCE
•10 years as an engineer in pharmaceutical/biotechnology regulated manufacturing environment.
•Direct experience with the operation, support, and design of the following systems: bioreactors, centrifugation, chromatography, tangential flow filtration, Clean-in-Place (CIP) systems, autoclaves, clean utilities, or HVAC systems
•Extensive knowledge of a variety of instrumentation and sensing technologies related to pharmaceutical manufacturing
•Experience with regulatory requirements and working in a GMP environment
•General familiarity with Batch-based control systems and Data Historian systems, SQL databases, Scripting languages (VB, etc.)
•Record of success in leading large capital projects

EDUCATION
•Bachelor of Science degree in Engineering or related field

Preferred
•Bachelor or Master’s Degree in Chemical Engineering or related field

COMPETENCIES AND SKILLS:
•Must have a demonstrated track record of successfully leading and executing engineering projects and supporting process operations in a FDA-regulated manufacturing environment.
•Possess knowledge of core principles in various engineering disciplines including fluid mechanics, heat transfer, thermodynamics, and mass transfer, as well as be experienced applying project management methodology
•Knowledge and experience developing and leading commissioning and qualification activities. Must also be able to suggest and drive improvements to current site programs.
•Proficient computer skills and be experienced using MS Office software (Word, Excel and PowerPoint) and MS Project.
•Embrace working in a fast-paced, team-oriented, cross-functional environment

Preferred
•Knowledge of process automation, programmable logic controllers, power systems, and controls highly desirable

LICENSES/CERTIFICATIONS:

Preferred
• Professional Engineer

PHYSICAL DEMANDS:
•Occasional climbing of ladders and lifting (25lbs) may be required
•Will occasionally work in clean-room environment and wear specialized garments (will require removal of make-up and jewelry)
•Must occasionally wear personal protective equipment (e.g. hard hats, safety shoes, safety glasses, ear plugs) due to safety
•Will occasionally work around chemicals such as alcohol, acids, caustics, buffers and bleach that may require personal protection

TRAVEL REQUIREMENTS:
•Infrequent travel but may approach 25% during project activities.

WHAT TAKEDA CAN OFFER YOU:
•401(k) with company match and Annual Retirement Contribution Plan
•Tuition reimbursement
•Company match of charitable contributions
•Health & Wellness programs including onsite flu shots and health screenings
•Generous time off for vacation and the option to purchase additional vacation days
•Community Outreach Programs

Empowering Our People to Shine

Learn more at takedajobs.com.

Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx

Keep your finger on the pulse of Medical Alley from anywhere with the ALLEY NEWSLETTER