44 applicants

Company

Original Job Post

Takeda · 3 days ago

Associate Director, Head of Production Engineering

Social Circle, GA

Full-time

Onsite

Director

$149K/yr - $234K/yr

8+ years exp

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Responsibilities

Direct the activities of the department/group.

Support site operations.

Provide SME level guidance.

Lead the equipment change management process.

Support and initiate Continuous Improvement projects.

Represent and support department/group during regulatory audits.

Lead corporate-level Engineering projects.

Support project management function for the site.

Responsible for group annual budget and LRP.

Maintain installed building network/systems.

Life-cycle planning and reliability.

Daily troubleshooting and monitoring.

Qualification

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Engineering disciplinesGMPsFDA guidelinesData Integrity Industry Guidelines21CFR part GAMPPurchasing practicesProcess validationMSOfficeMSProjectMSVISIOFDA-regulated manufacturingAutomationComputer system administrationSafety proceduresHardness testingCold environment workLoud environment workChemical handlingRespiratory protectionConfined area workSpecial gowningProtective clothing

Required

Bachelor's degree in science, engineering, or other related technical field

8+ years of related experience with 3+ in a management role

Well versed in engineering disciplines (e.g. fluid flow, thermodynamics, heat transfer, statics and dynamics, engineering materials)

Knowledge of GMPs, FDA guidelines (Data Integrity Industry Guidelines, 21CFR part 11, GAMP), purchasing practices, and process validation

Fluent with all MSOffice, MSProject, and MSVISIO software

Experience leading projects and operational supporting team in an FDA-regulated manufacturing environment

Understanding of automation, information technology, and computer system administration good practices, industry standards, and regulations

Ability to design outside of immediate scope of responsibility

May lift up to 50 pounds

May balance when performing jobs on top of the tanks and use of hardness to ensure safety is required whenever necessary

May work in a cold, wet environment

May work in a loud area that requires hearing protection and other protective equipment to be worn

May work around chemicals such as alcohol, acids, buffers that may require respiratory protection

Can work more than 8 hours a day or 40 hours a workweek as required

May work in a confined area as defined by the Environmental, Health, and Safety office

Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet, and body. This may include additional hearing protection for loud areas

Need to remove all make-up, jewelry, contact lenses, nail polish, and artificial fingernails while in the manufacturing environment

Work multiple shifts, including weekends, or be asked to work supplemental hours

Work around chemicals such as alcohol, acids, buffers, and Celite that may require respiratory protection