Location: Anasco, PR Shift: Monday - Friday full time, weekend and after hours may be required as needed.
Description: We are seeking a motivated and eager-to-learn Contractor 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. 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. This role offers an excellent opportunity for early-career engineers to gain 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.
Core Responsibilities:
Support packaging validation and testing activities for sterile and non-sterile medical device packaging systems.
Assist in the 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.
Qualifications:
Bachelors degree in Packaging Engineering, Mechanical Engineering, Biomedical Engineering, Industrial Engineering, or related technical discipline is required with at least 4+ years of engineering or manufacturing experience preferred.
Internship, co-op, or academic project experience within medical devices, manufacturing, quality, or packaging is preferred.
Must have previous experiences with tray-sealing process.
Protocals and execution - must have experience in cleanroom enviorments and protocols.
Regulated industry experience is required.
Exposure to regulated industries such as medical devices, pharmaceutical, or biotechnology manufacturing is a plus.
Basic knowledge of FDA QSR, ISO 13485, ISO 9001, or GMP environments preferred.
Familiarity with engineering documentation and data collection practices.
Exposure to laboratory testing, validation activities, or statistical analysis is preferred.
Interest in medical device packaging systems, sterile barrier systems, and validation methodologies.
Experience supporting engineering projects in a fast-paced environment is a plus.
Skills:
Strong willingness to learn packaging engineering principles and validation processes.
Ability to work collaboratively within cross-functional teams.
Good organizational and time management skills.
Basic analytical and problem-solving abilities.
Effective verbal and written communication skills.
Ability to follow established procedures, protocols, and engineering guidance.
Detail-oriented with strong documentation practices.
Basic understanding of engineering concepts and manufacturing processes.
Ability to understand, read, write, and speak English effectively.
Flexibility to support multiple shifts and weekend activities when required.
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).
Applicant Notices & Disclaimers
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At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.The pay rate for this position is $40.91/hr.
