Lab Equipment Qualification Engineer

Date: Jul 10, 2024

Location:

Haarlem, Netherlands, 2031

Company: Teva Pharmaceuticals

Job Id: 57018

Who we are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

The opportunity

As the Lab Equipment Specialist you will primarily focus on ensuring the efficient and compliant operation of sophisticated laboratory equipment used for analytical testing in the production of Cytotoxic drug products. This involves assessing, qualifying, validating, and implementing high-end laboratory equipment, managing related documentation, and ensuring adherence to regulatory standards. The role also focuses on continuous improvement, maintaining quality systems, coordinating with multiple departments and contractors, and acting as a key liaison between suppliers and the laboratory.

How you’ll spend your day

• Assess, qualify (including validation), and implement sophisticated high-end (computerized) laboratory equipment.

• Determine priorities within your project while tracking project execution across multiple departments.

• Oversee the timely completion of all validation documentation, including coordinating contractor activities.

• Support the regulatory defense of validation protocols and summary reports during audits and internal audits.

• Review quality system documents, including CAPA, change controls, investigations, and deviations.

• Develop and support continuous improvement initiatives for the validation of equipment, facilities, utilities, and control systems.

• Present project status to stakeholders and (senior) management.

• Write training instructions, calibration, maintenance, operational procedures, equipment specification files, and reports (URS, Risk assessments, IQ/OQ/PQ).

• Act as a Subject Matter Expert and actively participate during audits.

• Serve as the point of contact between suppliers and the laboratory.

• Manage contracts for maintenance and/or calibration.

• Manage computerized systems and applicable software.

• Develop Validation Master Plans, Validation Project Plans, and Project Schedules as needed.

Your experience and qualifications

• Bachelor or Master degree in the life sciences and have interest in IT environment

• Experience in the Pharmaceutical industry or an equivalent GMP environment for 4-5 years with at least 1 year experience on validation of laboratory equipment

• Organizational capabilities is part of your nature

• Team player with sound communication skills and pro-active approach.

• Experience with scientific analytical approaches

• Good knowledge of laboratory equipment with experience in calibration, qualification and validation

• Experience with deviations, changes and CAPA writing

• Good problem solving skills

• Support laboratory investigations as equipment SME

• Knowledge of Empower CDS (in combination with (U)HPLC and GC), particle analysis and basic analytical instruments is a pre

Contact person

Ivo Huijskens - Senior Recruiter Benelux & Nordics

Pre employment screening

Teva will carry out appropriate verification and legally permitted vetting prior to the confirmation of any offer of employment. More information on this verification and vetting will be provided if you reach this stage of the application process.

Reports To

Group Leader QC Planning and Coordination

Already Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply:Internal Career Site (https://performancemanager.successfactors.eu/sf/careers/jobsearch?bplte_company=1080030P)

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

EOE including disability/veteran