Location
Massachusetts | United States
Job description
Role: Manufacturing Engineer II
Location: Mansfield MA - 2048
Duration: 11 Months
Job Description:
ESSENTIAL DUTIES AND RESPONSIBILITIES
- To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
- Maintain and Support new and existing Operations Equipment
- Understand and be knowledgeable of Equipment and Process Operations completed in the facility.
- This includes, site SOPs, Equipment documentation, capacity, setup, operation, disassembly, maintenance, cleaning, troubleshooting, monitoring, and programming of manufacturing equipment and facility.
- Perform testing and troubleshooting on equipment to determine functionality level and capacity.
- To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Primary responsibilities are to:
- Create, update, and maintain equipment service work instructions.
- Organize and write validation protocols associated with the manufacturing process
- Lead and support troubleshooting activities to minimize process downtime or re-occurrence
- Identify key process indicators and collect data to drive manufacturing and yield improvements
- 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/or 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 and/or pharmaceutical manufacturing environment.
Job tags
Salary
