SRG, the leader in the Life Sciences human capital industry, is looking for a full-time, contract Manufacturing Engineer to join our client's pharmaceutical manufacturing team in Anasco, Puerto Rico.

*At this time we can only accept candidates currently living in Puerto Rico.

MUST HAVES:

• Minimum of 4-6 years of experience in the medical device and/or pharmaceutical manufacturing environment.
• BS in Engineering, preferably Mechanical, Industrial, Electrical, Chemical, or Biomedical (Professional Engineer License.) or sciences related field
• Lean/Six Sigma Green or Black Belt Certification is a plus
• Experience in validations such as: manufacturing equipment, manufacturing processes, stability or aging, required.
• Knowledge of FDA, OSHA, EPA, and GMP's and ISO requirements
• Written and verbal communications skills in Spanish and English

JOB RESPONSIBILITIES:

• Able to develop technical documentation such as: Change Controls, Validation Plans, Validation Protocols, Technical / investigation reports, SOPs, etc.
• Participate on cross-functional project teams including R&D, Quality Assurance, Supplier Quality, Planning, Purchasing, Regulatory, and manufacturing to maintain and improve surgical products.
• Responsible for reviewing and updating applicable product specifications and drawings for legacy products. Responsible for identifying acceptance criteria for product specifications.
• Develop project plans for qualifications and ensure team resources identified, team members help accountable to deliverables, and milestones met.
• Provide engineering knowledge and resolve design, manufacturing, and quality-related problems impacting existing products.
• Develop and issue change control documentation to address changes in components and/or raw materials requested by the suppliers following applicable procedures.

** 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.