Validation Specialist I - 60624 (Añasco)

*Title: Validation Specialist I - ***** (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 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 packaging testing, and validation activities for sterile and non-sterile medical devices.
* Internship, co-op, or academic project experience within medical devices, manufacturing, quality, or packaging is preferred.

*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 *****, ISO ****, 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 *****, ISO ****, 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 ******. 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:
* Bachelor's (Required)

Experience:
* Project Validation Engineer: 3 years (Required)

Language:
* Spanish (Required)
* English (Required)

Ability to Commute:
* Añasco, PR ***** (Required)

Work Location: In person