OBJECTIVES/PURPOSE (3-4 bullets)

The Purification Engineering Systems Specialist is integrated in the Purification Engineering structure.

The Purification engineering includes mechanical and automation engineering of purification systems and clean utilities (Process Compressed Air, Water For Injection, Deionized Water, Pure Steam, …). The purification consists in buffer preparations in process vessels, fluid transfers between vessels or throught filters/chromatoraphic columns/nanofiltration skids/Ultrafiltration skids, cleaning in place of equipments and sterile filtration to a sterile mobile vessel.

The position is to:

Create and improve engineering templates and documentation struture for Purification Plant EngineeringCoach Engineers to be efficient in the integration of validation aspects inside their tasks and projects.Write/Review projects documentation redacted by engineers before the official validation review.be involved to define for new projects and new tasks the qualification strategy

be a main support to prepare documentation to support and to present Engineering Activities in case of Audit.

ACCOUNTABILITIES (Describe the primary duties and responsibilities of the job.  Include only the essential functions of the job. Approximately 5 – 10 bulleted task statements should be identified).

Projects:

The incumbent is a validation expert supporting mechanical and automation engineering projects documentationsCoordinate engineering documentation activities (ressources, schedule and accountability on the action plan)Supports the definition of Validation Strategy

Major actor in qualification of systems :

Write and execute validation packagesBe on the floor to support tests and qualification.Recommend efficient improvement to qualify equipments and systems.

Operational Quality support:

Support site activities as a technical professional to facilitate investigationsAssure strict compliance with cGMP, 21 CFRs, GAMP5, Corporate, Divisional and regulatory requirementsPrepare synthetic presentation of validation strategy for “On Going” and Futur Projects and tasksUse problem-solving methodology

Daily activities:

Improvement of the department documentation structure.Creation/improvement of templates for Engineering activities (tenders, validation packages, ...)Periodic review of Engineering procedures and forms to ensure alignment with local/divisional proceduresCoach engineers and review of documentations before Validation Agreement.

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise (Breadth and depth of knowledge, application and complexity of technical knowledge)

Able to understand technical installations, equipments and sytems used on the site. Able to be a technical leader inside project development, investigations and routine problematics. Comfortable with technical & quality documentation according to GxP. 

Able to define the validation strategy of a new system or equipment.

Perfectly aware of current validation divisional procedure

Leadership (Vision, strategy and business alignment, people management, communication, influencing others, managing change)

Consistently exhibits Leadership Behaviors (Be Positive, Result-Driven, Accountable and excellent manager of himself and others) in the execution of activities, and encourages others to do the same.

Develop his or her leadership sensitivity in a multidisciplinary team. (Act as a technical leader).

Support validation strategy for AIMP, Business Continuity

Able to coordinate technical activities of up to 3 6 automation engineers.

Decision-making and Autonomy (The capacity and authority to make organizational decisions, autonomy in decision-making, complexity of decisions, impact of decisions, problem-soliving)

Able to be factual to report problematics and propose “ready to decide” solutions on complex issues and long term improvement plan

Interaction (The span and nature of one’s engagement with others when performing one’s job, internal and external relationships)

Collaborative and proactiv member inside a multi-disciplinary team. Able to interact with other departments with demonstrated communication skills.

Innovation (The required level of scientific knowledge, knowledge sharing, innovation and risk taking)

Leads benchmark and innovative ideas, propose innovation long term plan.

Complexity (Products managed, mix of businesses, internal and/or external business environment, cultural considerations)

Deploy Takeda EHS culture by applying security rules and giving regular positive and constructive feedback on initiatives that insure/improve the safety of the employees on the work floor.

He or She is aware of the complexity of products manufactured by TAKEDA Lessines, the complexity of aseptics aspects. He or She is also able to understand humans challenge complexity, to be able to respect any interlocutors by applying TAKEDA ethics code.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:  (List the essential and desirable education and competency requirements to perform the primary responsibilities of the job.  Any minimum requirements should be noted.)

Education / experience

Master degree in Biologics, Validation, Mechanics, Automation, Electrics: (Or Bachelor degree+ Exp.)5 years as a Validation Engineer with efficient technical skills.

Core Competencies / Skills / Leadership Behaviors

Experience with Quality Systems and Processes in a GMP regulated and FDA licensed manufacturing site.Good communication, leadership and organizational skillsMust be a team player prepared to lead, work in, embrace a team based culture.Has the ability to prioritize multiple tasks and work on multiple projects simultaneouslyClient oriented, rigorous, synthetic and analytic thinkingGood written and verbal skills in French and English.Must be sensitive to Data Integrity aspects.Must be proficient with standard office software (Word, Excel and PowerPoint)