Team Lead Process and Cleaning Validation

TIO, a pharmaceutical manufacturer in Oud-Beijerland, collaborates with its partners in the 'from idea to patient' process. This results in a comprehensive range of products. With around 400 generalists and specialists, we provide customized solutions in an innovative way, ensuring that everyone has access to the right medication. We are actively engaged in society and make significant efforts to be a reliable partner. That is important to us!

Over the course of 25 years, as a down-to-earth and healthy family company, we have formed a team that strives to deliver the right medication to the right patient in a timely manner. Each colleague plays a crucial role in this. TIO is ambitious and continuously invests in the development of our facilities and our people. Additionally, we place great value on collaboration and sharing knowledge and experience. This is important for our products and our people.

"We learn from today and strive to do a little better every day."

Due to continued growth, an exciting opportunity to lead and shape a high-performing team of validations specialist has been created.

Role description

The role of Manager Process and Cleaning Validation offers the opportunity to manage up to 6 validation specialists. The team manages all activities required for (ongoing) process and cleaning validation including the documentation (plans, protocols and reports); risk assessments (e.g. FMEA); mix and hold validation studies, monitoring and trending of data.

All process and cleaning validation activities are integrated within the Research & Development (R&D) department. The R&D department provides technical support to production departments and oversees both internal and external technology transfers. The final step of a successful technology transfer is to establish, during process validation, that all predetermined quality requirements of the (intermediate) product can be consistently achieved through the process. Throughout your work, you will maintain close collaboration with your peers to ensure timely realization of commercial productions. The dosage forms you will mainly work with include semi-solids, liquid dosage forms (including nasal sprays) and solid oral dosage forms.

Responsibilities

Lead and supervise a team of 6 Validation Specialists, providing guidance, support, and fostering a collaborative work environment.
Develop and implement validation strategies, protocols, and procedures for cleaning and process validation activities.
Ensure compliance with EMA and US FDA regulations, guidelines, and industry best practices.
Oversee the execution of cleaning and process validation studies, including protocol development, execution, and report generation.
Collaborate with cross-functional teams, including Research & Development, Quality Assurance, Manufacturing and Regulatory Affairs, to ensure alignment and successful validation outcomes.
Review and approve validation documentation, reports, and change controls related to cleaning and process validation.
Stay up-to-date with industry trends, regulatory changes, and advancements in cleaning and process validation practices.
Provide technical expertise and support to resolve validation-related issues and deviations.
Identify areas for process improvement and implement corrective actions as needed.

Requirements

Bachelor's or Masters degree (or equivalent experience) in Pharmacy, Chemistry, Pharmaceutical Sciences, or related field.
Proven experience of 5+ years in the field of cleaning and process validation within the pharmaceutical industry.
In-depth knowledge and understanding of EMA and US FDA regulations and guidelines pertaining to cleaning and process validation.
Strong leadership skills with the ability to effectively manage and motivate a team.
Excellent communication and interpersonal skills, with the ability to collaborate across different functions and levels of the organization.
Demonstrated problem-solving abilities and attention to detail.
Ability to work in a fast-paced, dynamic environment and effectively manage multiple priorities.

All work activities and client communication is in English, excellent English communication skills are required. The company language is Dutch.

What can you expect from us

A gross monthly salary between € 4.184,- and € 7.797,- based on a full-time employment contract. The exact salary will be tailored to your knowledge and work experience.

25 vacation days and 13 days of time-off in lieu (ATV days) based on full-time employment.

An attractive package of secondary benefits, including:

Premium-free pension plan.
Good travel expense reimbursement.
A lease bike plan. Enjoy the benefits of riding a bike for both business and personal use.
Enjoyable group activities, including yoga and boot camp.
Ample opportunities for personal and professional development.

For specific job-related questions, please contact Thijs Rooimans, Head of Research & Development. You can reach him at +31186 286 587 or trooimans@tiofarma.nl.

We look forward to a personal introduction!

If we find a suitable candidate before the closing date, the vacancy will no longer be available.

TIO does not accept unsolicited assistance from intermediaries/temporary employment agencies or any other third parties for this vacancy. Resumes (in any form) sent by the mentioned parties to any employee of TIO without a valid recruitment mandate will be considered public information. No fees will be payable to the mentioned parties in the event that a candidate is hired whose resume and/or other data were sent unsolicited. This also applies if the resumes are accompanied by other documents such as purchasing and/or delivery terms.

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