Manufacturing Engineer

Title: Manufacturing Engineer

Location : Massachusetts

Job Description:

ESSENTIAL DUTIES :

• 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.

Responsibilities:

• 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

• 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's 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 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