Validation Project Manager

vor 1 Tag

Basel, Schweiz Takeda Pharmaceutical Vollzeit

**About the role**:
Within the Engineering Services organization, reporting to the Engineering Services Lead, the Engineering Validation Project Manager is responsible for the management and the execution of Validation activities related to projects. He ensures compliance with regulations, Takeda policies, quality practices, and proper documentation.

The role is expected to have a solid understanding of industry pharmaceutical standards and validation compliance requirements and is required to supply support/technical knowledge for the development/refinement and implementation of validation standards.
**How you will contribute**:

- Provide direction and manage the assigned engineering validation team
- Set-up and development plan for Validation team members and follow-up the implementation of this plan.
- Evaluate, interview, and hire new resources, when applicable.
- Achieve validation team goals in respect to Validation tasks. Finance, Quality, Fulfillment and EHS.
- Schedule, plan, and manage validation activities related to manufacturing facilities, equipment, equipment cleaning, equipment sterilization, utilities, computerized and automated systems and work with team to prioritize Validation tasks, manage workload, remove obstacles and meet deadlines.
- Develop, review and approve procedures and validation documents (QRM, MVP, VPP, protocols, reports etc.) while complying with company’s quality policies, SOP’s and regulatory requirements
- Ensure compliance with regulations, Takeda policies, quality practices, and proper documentation
- Develop employees and potential leaders within the team and ensure high performance Validation Team.
- Ensure the development and completion of validation documentation according to quality & regulatory requirements and company policies
- Support investigation of non-conformities (deviations)
- Communicate status and validation topics in a clear and concise format
- Generate reports, progress metrics, KPIs and trends to measure performance
- Support other validation teams and tasks according to Neuchatel site and global requirements.**What you bring to Takeda**:

- We are looking for a strong energetic team player with good communication skills,
- Demonstrated interpersonal and expertise skills with ability to interface well with other departments, and lead effectively and efficiently validation engineering team
- Ability to manage multiple priorities in a manufacturing plant setting
- Ability to analyze, review and interpret engineering validation data
- Must have uncompromising dedication to quality and an excellent understanding of cGMPs and other regulatory guidelines
- Interpersonal skills that enables you to work with people at all levels
- Ability to plan, multitask, and manage time effectively
- Must display personal accountability for results and integrity
- Must display eagerness to learn, to innovate, drive for solutions and continuously improvement

**Education & Experiences**:

- Engineering degree or equivalent, preferably with biochemical or chemical background
- Min 7 years of experience in validation area
- At least 3 years’ experience in management
- cGMP and validation skills
- Broad validation knowledge, industrial trends and validation related literature
- Solid computer skills including Word, Excel, PowerPoint.
- Good English level (oral and written)
- Good French level (oral and written)

**What Takeda can offer you**:

- Attractive salaries
- Full accident cover
- Participation in health insurance premiums
- Advantageous retirement plans
- Subsidized meal
- Financial participation in the sports practices of its employees
- Transportation: support in local public transport, free parking, carpooling program
- Takeda Neuchâtel offers to its employees an attractive framework and working conditions. The well-being, safety, development and career development of its employees are at the heart of our vision and of our Human Resources, Health, Environment and Safety policies.
- Takeda Neuchâtel is an employer committed to its employees and future generations

**More about us**:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Empowering our people to shine:
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 religion, sex, sexual orientation, gender identity, gender expression, parental status, national

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