SRG, the leader in the Life Sciences human capital industry, is looking for a full-time, contract Project Validation Specialist III to join our client's pharmaceutical team in Anasco, PR. Responsible for assisting in the qualification of a new Multivac Machine to provide business continuity to the Collagen Business Unit.

*W2 contract only

MUST HAVES:

• BS in Engineering preferably Mechanical, Industrial, Electrical, Chemical, or Biomedical or science related discipline
• Minimum of 5 - 7 years of experience in the medical device and/or pharmaceutical manufacturing environment; with at least five (5) years in a validation engineering position
• Lean/Six Sigma Green or Black Belt Certification is a plus
• Experience in validations such as: packaging equipment, manufacturing equipment, laboratory equipment, cleaning, test method, computer systems, shipping, shelf life (aging), sterilization, facilities, clean rooms, and utilities (HVAC, Compressed Air, Water Systems) required
• Knowledge of Packaging components and equipment is highly desirable
• Knowledge of FDA, BSI, OSHA, EPA, and GMP's and ISO requirements

JOB RESPONSIBILITIES:

• Plans, develop, and implement documentation, procedures, and training necessary for the engineering team, production and quality personnel
• Generation and execution of change controls, validation plans, validation protocols (FAT/SAT/IQ/OQ/PQ/CSV's), and completion reports
• Develop statistically based sampling plans for in-process and final testing and inspections, and validations
• Review and approve validations and completion reports for new and existing products, processes and equipment
• Troubleshooting equipment/processes that do not perform as intended during validation runs. Recommend process/quality improvements as part of validation runs
• Work with new and existing equipment, processes, utilities, facilities and cleaning validations, to include (but not limited to) Packaging Equipment (e.g. Multivac Machine), freeze-drying, CCA, DIUF, RO/DI, WFI, Pure Steam, SIP Systems, HEPA Filters, chillers, controlled temperature units, and laboratory equipment.

** 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.