Validation Engineer

Validation Engineer 

Location: Leiden (onsite)

Contract till: Dec 2024

The Role: 

Under the direction of the Engineering Manager, manages and executes disciplinary projects regarding EHS, QA, business continuity and cost improvement. This includes problem definition, root cause analysis, project management, financial analysis, project development, efficiency or productivity improvement, and problem resolution. Role interfaces directly with other Mentor functional groups to ensure that goals/objectives are met within GMP/ISO compliance and product design changes are addressed appropriately.

Job Description / Responsibilities:

• Manages and executes projects of medium level of complexity insuring safety, regulatory compliance, company standards, operation requirements and business needs.

• Effective project planning and structure.

• Leads the optimization of process output and throughput, equipment utilization, equipment downtime, waste reduction/yield improvements, budget management, standard cost and capital investment management in an innovative manner.

• Provides technical support to the Production areas in evaluating process deficiencies, process changes, modifications and equipment failure. Defines, analyzes, reviews and evaluates problems for prompt solutions.

• Challenges the “status quo” on a routine basis and Develops new ideas within incoming processes.

• Coordinates phases of work with other departments within the company (Mentor).

• Technical support for Non-conformance issues in the manufacturing area generating root cause analysis reports and corrective action identification (Coordinates and participates on Cross Functional Investigation).

• Work on NCR/CAPA files from origination to full cycle completion and final approval.

• Supports manufacturing in the third line troubleshooting of equipments.

• Follows Standard Operating Procedures (SOP), Good Manufacturing Practices (GMPs), Company Policies and Federal, State and Local Government Regulations.

• Revise and maintain engineering, equipments and process procedure.

• Participates in GMP audits regarding equipment recording and machine performance.

• Coordinates communications and interfaces within end users (Mentor) and machine manufacturers or suppliers.

• Participates in projects involving other departments and activities.

• Comply J&J Safety Requirements and ensure safe working conditions and practices in the department.

• Responsible for communicating business related issues or opportunities to next management level

Qualifications:

• Bachelor degree in Engineering

Specific Knowledge and experience:

• Up to 2 – 4 years of experience in process or maintenance engineering in a Medical devices environment is preferred.

• Project management skills and training.

• Basic computer skills and use of software application(s). Strong computer background

• (MS Office, MS project Management, Power Point, Word, Excel, Outlook, Minitab)

• Experience in a manufacturing environment developing manufacturing standards.

• Experience of knowledge in short and long term project management.

• Regular organizational, interpersonal, oral and written communication skills.

• Ability to prioritize multiple commitments and technical problem solving ability.

• Ability to shift priorities according to changes in department/facility needs and be open to different ideas/approaches.

Additional knowledge, skills, 

• Knowledge – Has relevant knowledge of technical field.

• Leadership – provides significant contributions of project team and may lead multi- functional teams addressing medium projects. Broadens sphere of influence, including outside contracts.

• Financial management and scheduling – Prepare project estimates for design, equipment installation, labor, materials and other related costs. Prepare project forecast and schedules and track costs.

• Initiative – Works mostly independently. Plans and develops own methods, Takes actions in the absence of specific instruction. Develops and presents new or improved methods Solves manufacturing problems in a timely manner

• Contacts – engaged in contact with personnel at all levels within the organization.

• Dutch and/or English

• Ability to read, analyzes, and interprets general business periodicals, technical procedures, or governmental regulations.

• Ability to write reports, business correspondence, and procedure manuals.

• Ability to effectively present information and respond to questions from groups of managers, customers and other employees of the organization.

What’s in it for you?

As the biggest health company in the world, we find it important to put the needs and well-being of our customers and employees first. Our recipe for success consists of crafting an inclusive work environment where everybody feels welcome and respected.

At Johnson & Johnson, we blend heart, science and ingenuity to profoundly change the trajectory of health for humanity.

www.janssen.com

Benefits

This role offers a very competitive hourly rate.

about Johnson & Johnson

Janssen Vaccines & Prevention B.V. is one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and is passionate about the development, production and marketing of vaccines and antibodies to prevent and combat infectious diseases.

At the Leiden Site, talented and multi-skilled people are working in a high-performing culture in which innovation and a 'can do' state of mind are the central points. To build up and strengthen our Compliance team in Engineering, Validation and Maintenance (EVM) department we are looking for an enthusiastic and dedicated:

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email.

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”