CAM Bioceramics B.V. is the global number one manufacturer of choice for our partners who are looking for the highest quality and best service in the field of Orthobiologic Ceramics. We are working with the leading companies in the medical & dental (device) industries, start-ups with compelling business ideas and engaged universities. We co-op with our customers in the United States, Europe, Asia and in Emerging Markets. We will continue to seek and deploy technological and engineering advancements. If you’re passionate about your field, we have a wide array of positions available at our HQ in Leiden. The environment is innovative, energetic and full of opportunity. Our company thrives on a diverse workforce. Currently we are looking for a Method Development Engineer for our Quality Control department.
As a Method Development Engineer within a fast growing contract development and manufacturing organization you will be mainly responsible to manage and perform validation activities in support of the QC/QA organization. These activities consist of developing and authoring validation protocols and reports for analytical methods, authoring analytical methods, analytical method transfers, and development of methods. Strong knowledge of Analytical chemistry or biochemistry validation in order to be a subject matter expert during audits and technical troubleshooting in QC laboratories. Ensure that QC laboratories perform validation activities in compliance with cGMP and ICH Guidelines. Collaborate with other partners to deliver robust method for use in routine QC testing activities.
Author and Track execution of method validations and transfers in accordance to internal SOPs and ICH Guidelines. Provide ownership of the specifications, CAPA, NCR, Complaint Handling, Document Control, and Quality Records, and quality metrics, and any other QMS function as assigned. Coordinate with operations QC function. Adhering to Company policies, procedures, and directives regarding standards of workplace behavior in completing job duties and assignments. Being an effective team member by interacting and collaborating with others effectively, including in teams, in the workplace, and in culturally or linguistically diverse contexts
Main tasks and responsibilities:
- Act as Subject matter expert for audits and internal investigations;
- Planning and tracking of validation/transfer/development activities according to schedule
- Author/own QC methods and specifications;
- Collaborate with other departments to deliver robust methods for the execution in QC for release of product and Raw materials;
- Perform analytical method validation reassessments;
- Train and mentor junior level staff in validation/transfer requirements;
- Plan and own reports for control qualifications to ensure that they are readily available to QC testing laboratories;
- Coordinate and plan day to day QC validation activities with QC Testing management to agreed upon schedule;
- Provide QA oversight and/or review during the validation process for QC Analytical lab equipment and methods;
- Support the Engineering Team in evaluating all tests needed to qualify critical equipment, utilities, and processes;
- Perform compliance reviews of Validation Protocols and Final Reports in support of validation efforts;
- Develop and revise applicable SOPs and provides compliance oversight and support to QC department upon request;
- Perform compliance reviews of change control requests;
- Perform compliance reviews of all applicable Deviations, Investigations, and CAPAs related to qualification and validation;
- Review project, validation and change control documentation for the site’s QMS (Document Management/Compliance Modules) to assure compliance;
- Review and oversees execution FAT, SAT, and Commissioning of Equipment;
- Review and suggests continuous improvements to current validation practices, current quality system practices, validation protocols and procedures for newly installed equipment, and overall validation strategies;
- Other duties may include support to the Engineering Team in evaluating all tests needed to qualify critical equipment, utilities, and processes;
- Complies with policies and procedures in order to maintain compliance with legal regulations, health and safety, and regulatory requirements as written;
- Maintain the effectiveness of the position related processes of the Quality System.
Our ideal candidate has:
- Minimum of a Bachelor degree in a related field;
- Experience in a structured quality system environment (such as ISO 9001, ISO 13485, FDA part 820, FDA Part 210/211 or other), working in a Quality Department, preferably in a medical device environment;
- Experience and understanding of CAPA, complaint handling, nonconforming product (NCR) process, document control, Device History Record (DHR) product release, and quality system structure;
- Experience in fast paced and detail oriented environment heavy with requirements for complete and accurate documentation. Understanding of good documentation practices;
- Ability to successfully multitask;
- Organized, with good communication skills, and attention to detail;
- Team player, but resolute when needed, comfortable reporting to remote management;
- Comfortable making decisions within assigned authority, comfortable to escalate when needed;
- Able to train or mentor others that are new to quality system functions or practices;
- Quality systems internal auditor training or certification;
- Computer skills, Microsoft Office, and other as needed;
- Knowledge of 21 CFR Part 820 and/or 21 CFR Part 210/211;
- Experience with process validation including generating protocols, test scripts and writing final reports is strongly desired;
- Familiar with FMEA methodology.
If you think CAM Bioceramics B.V. may be a great fit for the next step in your career, please explore our available position below. We hope to hear from you soon. Please send us your motivational letter and resume via firstname.lastname@example.org with reference “Method Development Engineer”. If you need more information about this position please contact our HR department via email@example.com or +31 71 524 0680.