Sr. MES Specialist

Job Description

Senior MES Specialist

Kite, a Gilead Company

At Kite, we are at the forefront of immunotherapy and engineered T cell therapy. We are helping change the paradigm of cancer treatment and we are revolutionizing individually tailored treatments. That means a fast moving and constantly changing environment, where we make discoveries every day – discoveries that include our own capabilities and our individual potential.

We’re currently seeking to recruit highly motivated talents for different positions, to join us and be part of our exciting journey in the development of innovative cancer immunotherapies and their translation to the treatment of patients with cancer.

Department Description

As Manufacturing Process Engineer you’ll be joining a team in which employees of all backgrounds and experiences are respected, and where working together focused on saving lives, by finding the cure for cancer, is a daily activity. You’ll be reporting to the Manager Process Engineering (Manufacturing Systems Support).

You’ll be part of the Manufacturing Systems Support team (part of Manufacturing Technical Services) for our recently established manufacturing site in Hoofddorp (NL). In this role you will be part of a team responsible for deploying, maintaining and implementing changes in computerized systems in manufacturing (MES, LIMS, ERP etc) and plays a central role in the digitalization of manufacturing in Kite’s commercial manufacturing site, producing autologous T-cell therapy products.  The team also takes care of training, support and improvement projects around aforementioned systems.

Your responsibilities

MES EBR editor

• Understand the process and user requirements driven by process maps / flows in preparation for developing or updating EBR designs
• Convert process and user requirements into specific EBR designs and design elements (Basic Functions, Basic Operations, complex Formulas and ERP integration)
• Drive and support EBR design verification activities (lifecycle documentation generation, configuration/design testing and qualification)
• Manage EBR approval and retirement workflows to ensure correct record state
• Generate and maintain system life cycle documentation such as User Requirements Specifications, Configuration Specifications, and Functional/Design Specifications
• Lead design reviews and EBR version cut-overs with peers and a cross-functional stakeholder team

MES Key user

• Lead MES projects and change implementations

• Serve as part of the support group for MES users by analyzing and resolving issues and providing necessary instructions
• Escalate business continuity impacting issues to Process Owner and respective tier
• Support EBR impact assessments based on the manufacturing/business process requirements and changes
• Identify and document MES (business) and manufacturing process requirements.
• Identify and document improvement proposals
• Support Training materials development.
• Create and update Process SOPs, MES SOPs, and MES work instructions
• Provide input during design reviews of new and updated MBRs
• Provide input for lifecycle documentation generation and updates
• Organize and manage testing, qualification and review activities
• Keep knowledge up to date with MES application among users and stakeholders
• Participate in audits and inspections acting as MES subject matter expert

Your profile

Education

• Bachelor’s degree or equivalent experience

Knowledge and Experience

• 5 years’ relevant (process engineer/MES specialist) experience within a Pharmaceutical/GMP Manufacturing site
• Excellent knowledge of manufacturing processes
• Good experience with supporting users
• Experience with writing and execution of CSV documentation / protocols
• Experience in identifying opportunities for improvement, best practice and standardization
• Experience with GMP in a pharmaceutical environment, preferable cell therapy
• Experience with quality systems (change controls, deviations and CAPAs) in a pharmaceutical environment
• Knowledge of PAS-X version 3 is a plus
• Experience with SQL and XML coding with respect to MES is a plus
• Knowledge of the MES database and data elements as part of querying and reporting is a plus
• Experience with managing projects is preferred
• Good interpersonal skills

Personal skills

• Ability to take the lead and drive projects and changes

• Comfortable in a fast-paced expanding company environment and able to adjust workload based upon changing priorities
• Ability to function efficiently and independently in a changing environment
• Self-motivated, well-organized and willing to accept temporary responsibilities outside of initial job description
• Collaborate well in cross-functional matrix environment, ability to communicate and work independently with scientific/technical personnel
• Ability to think critically and demonstrated troubleshooting and problem-solving skills
• Good English language skills

Additional Requirements

Able to work on-Call / On stand-by outside office hours

As part of our recruitment process, you will be asked to complete a short 20-minute online Occupational Personality Questionnaire (OPQ) and/or a capability test.

Apply now!

Only candidates in possession of a valid EU work permit will be considered.

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company.  Except if otherwise provided by applicable law, all  employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws).  Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.