Laboratory Engineer

Laboratory Engineer  

Location: Leiden (onsite role) 

Hours: 40 hours, 12 months contract

Essential: Fluent English, experience within validation, lab investigations, statistical analysis, lab systems, quality - previous background within pharma or medical devices  

The Role:

The position of Lab Engineer reports directly to the Quality Laboratory Lead. Oversees the activities within Lab support and ensures that systems within the Quality system are adequately maintained and assist/replaces/back up the Quality Lab Lead and/or Sr Supervisor Lab Operations as needed and requested from a broader scope within the Quality Management system and as defined in the Duties & Responsibilities section of this document. 

Furthermore, the Senior Lab Engineer is accountable for delivering a contribution to the making of high quality products that is done by development and improvements of laboratory testing.

Key Responsibilities:

Under and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• Follows Standard Operating Procedures, Good Manufacturing Practices, Company policies and Local Government Regulations;

• Supports, consults, trains on, and leads quality (improvement) projects throughout the life cycle of Mentor products within the QC scope, this may include product design and development, manufacturing, purchasing and other improvements;

• Utilize statistical tools and techniques to establish data trending activities;

• Oversees the activities within Lab support and delegates tasks to other support team members.

• Supports engineering activities in-process and vendor specification development; 

• Analyzes process-, product-, test- and Quality Management System data and investigates for improvement opportunities. 

• Lead and/or reviews validations documentation (eg. IQ, OQ, PQ and verification studies).

• Leads or is team member of CAPA investigation and action plans.

• Leads or is team member of Internal audit observation investigation and action plans.

• Investigate instances of nonconforming material and supports the determination of cause, corrective action and recommendation of the disposition of product.

• Ensures that software validations are performed according to applicable FDA guidelines. Provides end user support by software validation throughout the Software Validation Life Cycle at The Netherlands Operations. 

• Evaluates compliance with applicable laboratory standards and procedures;

• SME during projects, regulatory, MDD and notified body audits/inspections;

• Defining, developing and improving laboratory procedures;

• Revise and maintain laboratory procedures;

• Participates when necessary in projects involving other departments and activities; 

• Coordination of non-routine laboratory testing activities including validation testing;

• Implementation of corrective and preventive action and quality data trending for CAPA review board evaluation;

• Test database maintenance (Labware LIMS program activities & SME);

• Oversees and support day-to day laboratory trouble shooting for test equipment and unexpected test results;

• Writing and bi-annual review of Service Level Agreements;

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

• Is responsible for annually review of Bioburden Data and Environmental Monitoring Data as part of routine trend analysis;

• Is responsible for quarterly trend report to be used in DRB.

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

• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

• Comply with all applicable environmental, safety and occupational health policies

Profile

• Bachelor or Master degree in Engineering, Science or Microbiology.

• Minimum of 2-4 years of related experience within Pharmaceutical and/or Medical Device companies, with relevant QC or QA experience. In-depth knowledge of ISO 13485.

• Has an advanced broad and in-depth knowledge/familiarity with laboratory testing and automation;

• High level of accuracy;

• Trouble shooting and analytical minded;

• Planning skills, ability to prioritize multiple commitments and technical problem solving ability;

• Good interpersonal skills, engaged in contact with personnel at all levels within the organization;

• Good communication skills, ability to write protocols/reports, business correspondence, and procedures; 

• Pro Active, works independently, takes actions in the absence of specific instruction;

• Develops and presents new or improved test methods, solving laboratory problems in a timely manner;

• Fluent in English; Dutch (nice to have)

• Team player.

Benefits

This role offers a competitive hourly rate & a supportive working environment. 

About Johnson & Johnson MedTech

At Johnson & Johnson MedTech, we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible.

For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health. In surgery, orthopaedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalised.

https://www.jnj.com/healthcare-products/medtech

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. Please apply via the link.

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”.