Professional services contract.
Please read all carefully before applying.
Duration: Depends on project's schedule (long term)
Where: Añasco, On-Site
Hour Rate: Depends on the expertise. Negotiable
MINIMUM QUALIFICATIONS
Education and/or experience:
- BS in Mechanical Engineering, Industrial Engineering, Chemical Engineering or related science.
- Experience in the medical device and/or pharmaceutical manufacturing environment; on a project validation engineer position.
- Experience on EUMDR is a must.
Responsibilities:
- The position is to support the European Union Medical Device Regulation (EU MDR) program. The incumbent will be supporting the following activities to ensure conformance with EU MDR for technical filing of products manufactured, included in the EU MDR program:
- Data Gathering – Participate in the discovery and compilation of required documentation to be evaluated.
- Gap Assessments – Assess of all manufacturing documentation such as product device master record (drawings, specifications, bill of materials, production router/instructions, procedures, labeling), process flow charts, incoming inspections, in-process inspections, final inspections, validation plans and process validations, among others.
- Remediation Plan – Perform tasks identified as part of the remediation plan including, but not limited to: validation documentation generation and execution (change control, validation plans, validation protocols, validation closure reports, technical reports / memos) and manufacturing documentation update through site change orders system.
The incumbent will be working with cross functional areas on activities described above. Responsible for the delivery of tasks to ensure conformance to the project plan schedule.
Perform assessments and review of all manufacturing and validation documentation associated to product families established by EU MDR program. Provide data to support the gap assessments reports and identify remedial action items based on the outcome of gap assessments. Complete assigned remediation activities to ensure that manufacturing processes and operations are in compliance with requirements of EU MDR. Generate and execute validation protocols, including the coordination of all activities required for protocol completion. Interact and coordinate activities with other departments, external vendors, and customers, as required. Update documentation associated with manufacturing processes which can include drawings, specifications, bill of materials, production router/instructions, procedures, labeling, and process flow charts, among others. Provide training in the updated manufacturing documentation as applicable. Analyze manufacturing process information / data, develop, where necessary, technical justification, rationale and/or other information as required by the company to mitigate risk to acceptable level with adequate documentation. Report project status and progress periodically to site management. Perform other related duties, as required.
Work on official documentation to address technical issues on equipment/processes. Perform Remediation activities as deemed required.
Qualifications:
- Knowledge of FDA, OSHA, EPA, and GMP's and ISO requirements.
- Must have knowledge of European Union Medical Device Regulation (EU MDR 2017/745), European Union Medical Device Directive 2007/47/EC and ISO13485:2016 Medical Devices – Quality Management Systems.
- Must have a thorough understanding of verification and validation processes.
- Must have excellent communication skills and a strong track record of working cross-functionally.
- Experience with managing documents within electronic PLM system.
- Must have demonstrated ability to think strategically.
- Must be able to develop technical documentation such as: Change Controls, Validation Plans, Gap Assessments, Validation Protocols (IQ/OQ/PQ), Technical / investigation reports, SOP, and others.
- Teamwork oriented and self-starter.
Other Requirements:
- Excellent interpersonal and communication skill at all levels.
- Fully bilingual (English and Spanish).
- Must speak Spanish fluently (native).
- Teamwork oriented and self-starter.
- Need to have full attention to details.
- Skills in working under time pressure.
- Availability to work extended hours in a day and weekends if required.
- Available to start as soon as possible.
- Must live in Puerto Rico. No relocation nor travel expenses available.
- Resumes must be in English.
- Please, only apply if you are qualified for this position.
Job Types: Full-time, Contract
Application Question(s):
- Do you have an engineering or related science bachelor degree?
Education:
Experience:
- Project Validation Engineer: 3 years (Required)
Language:
- Spanish (Required)
- English (Required)
Ability to Commute:
- Añasco, PR 00610 (Required)
Work Location: In person
