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Job Description

The Production Engineering Manager will oversee technical support for ramp-up and steady-state commercial manufacturing operations within the Albumin, IG, and/or departments at Takeda in Covington, GA.  This includes day-to-day engineering and troubleshooting for the manufacturing process, automation, and equipment.  The Production Engineering Manager leads a team of approximately 12 engineers that provide 24/7 on-site support.

Primary responsibilities of this role include:

Manage and direct the work of approximately 12 on-shift Production Engineers in providing leadership, technical support, and real-time decision making in the following areas:IG, and/or Albumin Purification processesProcess equipment (vessels, UF/DF, robotics, COP washers, CIP skids, CMS & ANX Chromatography columns, SPTFF skid, nano filtration skid)Distributed Control System (DeltaV) and Process Logic ControllersManufacturing Execution System (Simatic IT)Automation hardwareIn Process Testing lab (pH, conductivity, titration)Process managementSafety and quality investigationsSystem ownership of Process Testing equipment

Develop the Production Engineering team into customer-oriented, manufacturing experts capable of providing operational ownership of unit operations, engineering assessments for change control and event investigations, as well as technical representation for regulatory and safety agencies

Drive continuous improvement within the GMP manufacturing organization with focus on:Reducing manufacturing events, user interventions, and batch record alertsIdentifying opportunities and delivering projects to reduce cycle time, error proof operations, and eliminate wastePerforming operational assessments to ensure proper processes, procedures, and training are in placeDeveloping Manufacturing Unit Team initiatives and leading Continuous Improvement effortsDriving actions through a change control process to implement process improvements

Create a learning culture within the manufacturing organization that fosters team development through:Leading knowledge transfer training with manufacturing and engineering staffCoaching manufacturing staff while partnering with them to resolve technical issuesDeveloping troubleshooting guides for common problemsSharing process knowledge with colleagues across all shiftsProvide systems to ensure consistent business performance by:Committing to employee feedback and developmental processesDefining and maintaining team metrics which drive improved business resultsAssisting the department heads to meet the annual operating plan, budgetary commitments, and continuous improvement initiativesPreparing budgets and forecasts for areas of responsibilityAssuring compliance to all regulatory requirements – FDA, OSHA, EPA, etc.Maintaining environmental, health, safety, and quality performanceSupporting plant-wide strategic plan programs and activities

Education and Experience Requirements

Bachelor’s degree from an accredited institution in an engineering or scientific discipline with a minimum of 8 years of experience within the pharmaceutical, biotechnology, or comparable environmentDemonstrated record of successful execution within a manufacturing environment, success within an FDA regulated environment is highly preferred

Key Skills, Abilities, and Competencies

Advanced supervisory and leadership skills, including demonstrated ability to coach, provide feedback, and develop both teams and individualsExcellent technical and troubleshooting skillsWorking knowledge of core engineering principles in various disciplines (chemical, mechanical), unit operations (precipitation, centrifugation, filtration, UFDF, CIP, COP, robotics, chromatography), support systems (WFI, RO, clean steam, HVAC), and facility designAbility to make independent decisions and solve challenging manufacturing problems without assistanceAbility to lead cross-functional teams, exert broad influence, and work as a collaborative team memberAbility to communicate effectively across the organization both verbally and in written formAbility to provide 24/7 on-call support and work overtime as requiredAbility to perform a combination of activities including both office and manufacturing tasksAbility to work in controlled environments with gowning restrictions including protective clothing covering the head, face, hands, feet, and body; no make-up, jewelry, nail polish, or artificial fingernails may be worn in the manufacturing environmentAbility to work in a loud area that requires hearing protection and other protective equipmentMust be able to lift up to 30 lbs.Prolonged periods sitting at a desk and working on a computer.Frequently or constantly to lift, carry push, pull, or move objects and repetitive motions.Subject to inside environmental conditions.Work is performed in an office setting.Position requires a combination of sedentary work and walking around the facility.Must be able to work multiple shifts, including weekends if needed/required.Non-Exempt roles must be able to work overtime when required.Some clean room and cool/hot storage conditions.May be required to work in a cold and/or wet environment.Maybe required to work in confined spaces.May be required to enter controlled environments requiring special gowning. No makeup, no jewelry, contact lenses, nail polish, artificial fingernails maybe worn in the manufacturing environment.Travel for this position will include less than 10% locally usually for training purposes

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. 

For Location:

USA - GA - Social Circle - Hwy 278

U.S. Base Salary Range:

$108,500.00 - $170,500.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. 

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. 

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

LocationsUSA - GA - Social Circle - Hwy 278

Worker TypeEmployee

Worker Sub-TypeRegular

Time TypeFull time

Job Exempt

Yes