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).

 
 
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.