Title: Sealing Validation Specialist II - 60715 (Añasco)
Job Type: Professional services contract.
Duration: Depends on project schedule (long term)
Where: Añasco, On-Site
Hour Rate: Depends on the expertise. Negotiable
MINIMUM QUALIFICATIONS
Education and/or experience:
- BS in Packaging Engineering, Mechanical Engineering, Biomedical Engineering, Industrial Engineering or related science.
- Must have experience in the medical device and/or pharmaceutical manufacturing environment; on a project validation engineer position.
- Must have experience on packaging and sterility barrier testing, and sealing machines validation activities for sterile and non-sterile medical devices.
Responsibilities:
We are seeking a motivated Validation Specialist to support the Project Engineering Department in packaging testing, and validation activities for sterile and non-sterile medical devices. This position will work closely with senior packaging and project engineers to support packaging system implementation, technical documentation, testing coordination, and continuous improvement initiatives within a regulated medical device manufacturing environment.
The ideal candidate is a hands-on team player with strong organizational and communication skills, a technical curiosity, and a willingness to develop packaging engineering expertise through practical project experience.
Exposure to medical device packaging validation, regulatory requirements, and cross-functional project execution.
The selected individual must also demonstrate flexibility and availability to support different shifts and weekend activities as business needs require.
Skills:
- Packaging engineering principles and validation processes.
- Ability to follow established procedures, protocols, and engineering guidance.
- Understanding of engineering concepts and manufacturing processes.
Qualifications:
- 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.
- Knowledge of FDA QSR, ISO 13485, ISO 9001, or GMP environments preferred.
- Exposure to laboratory testing, validation activities, or statistical analysis is preferred.
- Execution of packaging studies, validation protocols, and engineering evaluations under the guidance of senior engineers.
- Collect, organize, analyze, and document testing data to support validation efforts and engineering decisions.
- Support Engineering activities through setup, sample preparation, data collection, and documentation activities.
- Assist with technical documentation including protocols, reports, test summaries, specifications, and change records.
- Coordinate activities with cross-functional teams including Quality, Operations, Regulatory and Product Development.
- Support troubleshooting activities related to packaging performance, manufacturing, or testing issues.
- Assist with risk assessments, continuous improvement initiatives, and process optimization projects.
- Ensure compliance with internal procedures, FDA QSR, ISO 13485, ISO 9001, MDR, CDMR, and applicable regulatory requirements.
- Maintain accurate project records and support timely completion of assigned deliverables.
- Participate in packaging line trials, validation builds, and manufacturing support activities as needed.
- Provide on-site support across different shifts and weekends as required by project and operational needs.
- Demonstrate initiative, accountability, and willingness to learn new technical skills and regulatory requirements.
Other Requirements:
- Ability to work in ISO 7-class cleanroom environments using required gowning for extended periods of time.
- Proficiency in Microsoft Office applications (Excel, Word, PowerPoint preferred).
- Experience with managing documents within electronic PLM system.
- Good organizational and time management skills.
- Basic analytical and problem-solving abilities.
- Excellent interpersonal and communication skills at all levels.
- Fully bilingual (English and Spanish). Must speak Spanish fluently (native).
- Strong track record of working cross-functionally.
- Must have demonstrated ability to think strategically.
- 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. Flexibility to support multiple shifts and weekend activities 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.
- We seek experienced professionals; no training will be given on the position requirements.
- Please note: This position does not offer visa sponsorship. Applicants must be fluent in both Spanish and English. Kindly refrain from applying if you do not meet these requirements. No C2C available.
- Are you a match? Please apply to Indeed position or send your updated resume to [email protected]. Please include the job title in the subject line.
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
