SRG, the leader in the Life Sciences human capital industry, is looking for a full-time, contract to Medical Device Packaging Validation Specialist to join our client's medical device manufacturing team in Anasco, Puerto Rico. The position will be supporting the Packaging Requalification Program to ensure conformance with ISO 11607 for all SKU's packaged at the facility.

*Applying candidates MUST currently live in Puerto Rico.

MUST HAVES:

• Minimum of 5 - 7 years of experience in the medical device and/or pharmaceutical manufacturing environment; with at least five (5) years in manufacturing process, quality or validation engineering position and preferably with exposure to Packaging Validations, Design Control and Product/Process Transfer.
• BS in Science or Engineering, preferably Mechanical, Industrial, Electrical, Chemical, or Biomedical.
• Knowledge of ISO 11607 regulations for sterile barrier packaging, remediation projects, compliance projects, process validation and/or packaging validation projects required.
• Knowledge in shelf-life validation (aging studies), sterile barrier sealing process validation and packaging validation.
• Thorough understanding of packaging and transit (transport) testing and performance test methods (conditioning, compression testing, drop testing, vibration testing, bubble leak test, among others).
• Experience with managing documents within electronic PLM system.
• Knowledge of FDA, OSHA, EPA, and GMP's and ISO requirements.

JOB RESPONSIBILITIES:

• Document Generation - Generate all documentation required, included but not limited to Change Control, Validation Protocols, Drawings, Routers, etc identified as required as part of the project needs.
• Validation Executions - Participate in the validation activities (IQ, OQ, PQ, Shipping and Shelf Life, TMV etc.) required to ensure compliance with ISO 11607 as part of the project deliverables.
• Complete package and sealing integrity tests as well as package seal strength tests such as: seal strength (peel) test, burst test, creep test, bubble leak test and dye penetration, among others.
• Proficiency in usage of Minitab and equivalent tools to perform advanced statistical analysis.
• Able to develop technical documentation such as: Change Controls, Validation Plans, Validation Protocols, Technical / investigation reports, SOP, and others.

** Only candidates selected to be moved forward in the recruitment process will be contacted by SRG's Recruitment Team to schedule a conversation.

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.