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Hello,

This is Preethi from Intellectt Inc. Please find the requirement details below

Role: Manufacturing Engineer

Location: Mansfield, MA - 2048

Duration: 6 Months on W2

Responsibilities:

• Generation and execution of validation plans, validation protocols (IQ/OQ/PQ), and completion reports, with a major focus on sterilization and microbiology of medical devices.
• Provide statistical analysis of the date to support the reports.
• Generation and implementation of change controls and engineering notices (ECO).
• Develop statistically based sampling plans for in-process and final testing and inspections, and validations.
• Troubleshooting equipment/processes that do not perform as intended during validation runs.
• Recommend process/quality improvements as part of validation runs.
• Evaluate, investigate and document non-conformances incidents and/or protocol deviations.
• Complete assigned Non-Conformance and CAPA investigations and prepare investigation reports.
• Develops and maintains an effective cross-functional working relationship with plant and corporate Manufacturing, Engineering, Regulatory, and Quality Assurance personnel.
• Work on project teams with other internal departments, external vendors, and customers as required.
• Assure that existing processes and assigned activities fully comply with regulatory and/or international agencies, such as FDA, ISO, OSHA, EPA, among others.
• Participate in the compilation and review of technical documentation for both domestic and international regulatory submissions.

Participate in external audits such as:

• FDA, Notified Body (BSI) and Corporate, among others.
• Performs other related duties as necessary.

Qualifications:

• Knowledge of FDA, OSHA, EPA, and GMP and ISO requirements.
• Knowledge in Organizational Excellence and Lean/Six Sigma.
• Strong Project Management skills.
• Ability to lead teams through complex projects and provide departmental technical leadership.
• Must have excellent communication skills and a strong track record of working cross-functionally.
• Must have demonstrated the ability to think strategically.
• Able to develop technical documentation such as: Change Controls, Validation Plans, Validation Protocols, Technical / investigation reports, SOP, and others. Teamwork oriented and self-starter.

Education and Experience:

• 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.
• Minimum of 4-6 years of experience in the medical device or pharmaceutical manufacturing environment.