Engineering Services Lead

Takeda•Lexington, MA

23h•Onsite

About The Position

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.

Requirements

Engineering degree or equivalent
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
Strong interpersonal skills and communication abilities.
Able to manage up and across the organization
Sound business acumen and ability to align engineering services with business needs and within financial constraints.

Nice To Haves

Specialization in Chemical, Biochemical, Mechanical or Industrial engineering
Minimum of 5 years of people leadership experience
Prior experience interacting with the FDA and other regulatory agencies
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

Responsibilities

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
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.
Set objectives, delegate tasks, and ensure operational success, with reviews by senior management.
Help shape company policies, tackle complex problems, and meet budgets and schedules.
Manage projects, influence organizational goals, maintain frequent communication with peers and customers, and lead teams and projects, serving as a best practice/quality resource.