Sr Process Engineer II

Takeda is a patient-focused, values-based, R&D-driven global biopharmaceutical company committed to bringing Better Health and a Brighter Future to people worldwide. Our passion and pursuit of potentially life-changing treatments for patients are deeply rooted in over 230 years of distinguished history in Japan.

“Every vial has a name” is a core value at our Thousand Oaks CA campus, a multi-product facility with over 20 years of operational expertise. We have

Summary

Under the direction of the Head of Process Engineering, this position is responsible for providing support for operations and projects for manufacturing at the Rancho and Lawrence Manufacturing Facilities in Thousand Oaks. Establish engineering discipline and practices that support operations while improving functionality. Responsible for the engineering aspect of the process and equipment with regards to projects, manufacturing issues, troubleshooting, investigations and improvements. Ensures cGMPs, SOPs, Company Procedures, and Good Engineering Practices are appropriately integrated in all activities.

Responsibilities

• Equipment / Process expertise to perform complex troubleshooting of process, equipment failures or malfunctions and/or the development of technical assessments
• Applies engineering principles to the design and implementation of major system modifications, process and/or capital projects
• Perform process monitoring, assess process impact, and provide technical troubleshooting
• Strong knowledge on Biopharmaceutical operations and processes such as filling machines (Isolators and RAB technology), capping machines, parts washers, autoclave, lyophilizers, packaging machines and aseptic processes.
• Provide technical expertise/guidance and lead investigations for process related deviations, change control and operational excellence projects
• Demonstrate project management skills and application of concepts.
• Experience in investigation of deviations, development of corrective and preventive actions and generation and implementation of change controls
• Contribute to and administer standards, policies and good engineering practices
• Assess/analyze, advise and propose improvements for delivering higher productivity, reliability, capacity and compliance
• Partner with other engineering teams for providing efficient, proactive and effective support to Manufacturing
• Collaborate with cross functional teams as required
• Establish, develop and drive Good Engineering Practices; ensure that they are applied in all support and project activities.

Education & Experience Requirements

• Bachelors Degree in Engineering; preferably Chemical/Mechanical Engineering
• Minimum 5 years of experience with process engineering, design, process improvement and projects
• Scope requires an in-depth knowledge of pharmaceutical or food industry process equipment relevant to process equipment, and general working GMP knowledge of pharmaceutical manufacturing facilities and utilities.

Key Skills and Competencies

• Strong process engineering skills based on sound engineering and scientific principles preferably with a bio-technology foundation.
• Must have strong communication skills in order to effectively communicate with all levels of professionals, both internal and external
• Excellent in systematic trouble shooting and problem solving skill
• Demonstrated leadership skills and decision-making experience
• Background in biologics tech transfer into commercial facilities
• Independently motivated with successful ability to multi-task and work in teams
• Excellent written and verbal communication with experience with technical writing and presentations
• Process optimization and change control experience.
• Experience leading and mentoring less experienced engineers. Supervisory experience is a plus.
• Some experience running projects large or small (experience with creating schedules and cost estimates, as well as common project management tools like MS Project)

• Living our leadership behaviors is a basic expectation for all Takeda employees. Takeda expects all employees to embody the following:
  

Leadership Behaviors

• Be Positive
• Be Accountable
• Be Results Oriented
• Be An Excellent Manager of Self and Others

Complexity and Problem Solving

• Day to day engineering decisions not impacting established scope, cost, or schedule are within this resource’s authority.
• Engineering decisions that impact established project scope, cost, or schedule must be communicated to a higher level.

Other Requirements

• Must be able to work in controlled environments requiring special gowning.
• 25-35% travel.
• Must be able to lift, push, pull and carry up to 50 lbs.

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USA - CA - Thousand Oaks - Rancho Canejo

Employee

Regular

Full time

Job ID R0027568