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Job Description

About the role:

The Engineering Services Lead is responsible for ensuring that equipment and systems are fully qualified and meet design requirements throughout the asset lifecycle. This role involves overseeing the design and development test plans, validating functional requirements, and benchmarking system performance. By leading teams and projects, this role contributes to Takeda's mission of delivering high-quality products.

How you will contribute:

Empower, develop, and support staff members to ensure validation requirements are applied as “fit for purpose” for the manufacture of drug substance while meeting Regulatory, Quality, Capacity and EHS requirements.
Responsible for oversight of the validation maintenance and project activities at the MBO site that includes qualification of equipment, critical systems/utilities, computerized systems, facilities, cleaning and sterilization process qualifications.
Provides leadership to validation disciplines during the development of the project requirements, scope, design (concept, basic, and detail), timeline, and budget#
The incumbent is responsible to improve existing validation processes to ensure compliance while also driving efficiencies. Provide leadership to all validation related investigations
Develop and implement strategies to drive efficiencies in cost and time within the validation maintenance and project activities.

Skills and qualifications:

Engineering degree or equivalent required with a specialization in Chemical, Biochemical, Mechanical or Industrial engineering preferred
Minimum of 5 years of people leadership experience preferred.
Demonstrates strong leadership skills, capable of guiding teams to achieve operational success and project goals
Fully independent in systems engineering tasks, capable of handling highly complex situations and advising others on integration and lifecycle management
Proven engineering experience in a GMP environment and prior experience interacting with the FDA and other regulatory agencies preferred
Thorough knowledge of Validation process in Pharmaceutical Manufacturing and experience in manufacturing processes, control systems, cleaning processes, process equipment, facilities, temperature-controlled units and critical support systems preferred.

Job Description

About the role:

How you will contribute:

Empower, develop, and support staff members to ensure validation requirements are applied as “fit for purpose” for the manufacture of drug substance while meeting Regulatory, Quality, Capacity and EHS requirements.

Responsible for oversight of the validation maintenance and project activities at the MBO site that includes qualification of equipment, critical systems/utilities, computerized systems, facilities, cleaning and sterilization process qualifications.

Provides leadership to validation disciplines during the development of the project requirements, scope, design (concept, basic, and detail), timeline, and budget#

The incumbent is responsible to improve existing validation processes to ensure compliance while also driving efficiencies. Provide leadership to all validation related investigations

Develop and implement strategies to drive efficiencies in cost and time within the validation maintenance and project activities.

Skills and qualifications:

Engineering degree or equivalent required with a specialization in Chemical, Biochemical, Mechanical or Industrial engineering preferred

Minimum of 5 years of people leadership experience preferred.

Demonstrates strong leadership skills, capable of guiding teams to achieve operational success and project goals

Fully independent in systems engineering tasks, capable of handling highly complex situations and advising others on integration and lifecycle management

Proven engineering experience in a GMP environment and prior experience interacting with the FDA and other regulatory agencies preferred

Thorough knowledge of Validation process in Pharmaceutical Manufacturing and experience in manufacturing processes, control systems, cleaning processes, process equipment, facilities, temperature-controlled units and critical support systems preferred.

Engineering Services Lead

Job Description

Engineering Services Lead

Job Description

Locations

Worker Type

Worker Sub-Type

Time Type

Takeda

Takeda

Benefits

Takeda