Process Engineer
Process Engineer
Posted on :
05-06-2025
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1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
05-06-2025
Job Description
Ultimate Solutions Corp is a global leader in compliance and technology solutions specializing in end-to-end integrated services for the Life Science industry. With 19 years of experience we have built core competencies by combining regulatory and quality expertise with advanced packaging automation serialization brand protection and IT services. This unique blend of capabilities has enabled us to expand our reach to client worldwide.
Process Engineer
RESPONSIBILITES
EDUCATION
Bachelors degree in Engineering (3 - 6 years of experience)
REQUIREMENTS/SKILLS
Ultimate Solutions Corp is an equal opportunity employer.
Process Engineer
RESPONSIBILITES
- Lead/support projects or initiatives including but not limited to: new products process and technology introductions.
- Participates in projects involving other departments and activities.
- Coordinates communications and interact within end users and machine manufacturers or suppliers.
- Evaluates process trends (Ex. Yield OEE) to drive improvements of business results.
- Responsible for problem identification root cause analysis project management financial analysis efficiency or productivity improvement and problem resolution.
- Support process improvement projects that have the objectives of developing more cost efficient and quality enhanced processes.
- Evaluate data generated through studies using statistical analytical methods.
- Responsible for the development and/or revision of production standards and Manufacturing/Packaging process to assure utilization of best process.
- At higher levels may lead and direct the work of others.
- Build and execute validation strategies.
- Must possess a solid understanding of FDA Validation guidelines.
- Implements policies and procedures to validate/qualify equipment systems and processes in accordance with regulatory requirements and company manufacturing standards.
- Generate new specifications based on new regulations required by the implementation of a new manufacturing process.
- Generates executes reviews and complete qualification and validation protocols summary reports and associated data for conformance to regulations SOPs specifications and other applicable acceptance criteria.
- Prepares and coordinate qualification activities.
- Communicate with the staff and management on ways of implementing plans and recommendations.
- Responsible for designing document and implementing manufacturing and/or packaging processes & equipment.
- Familiar with a variety of field concepts practices and procedures.
- Six Sigma Certification desirable
EDUCATION
Bachelors degree in Engineering (3 - 6 years of experience)
REQUIREMENTS/SKILLS
- Experience in Medical Device or Pharmaceutical industry is required
- Project Management experience managing multi-sites project is a plus
- GMP & ISO knowledge understanding and experience
- Computer skills and use of software application(s). Strong computer background (MS Office MS Project Management Word Excel Outlook etc.)
- Strong knowledge on statistics problem solving and lean tools.
- Effective interactions in a team environment
- Team player self-starter persistent tactful and persuasive
- Good organizational skills detail-oriented & accurate analytical skills
- Effective verbal and written communication skills (writing and presentations)
- Able to work with minimum or no supervision
- Fully Bilingual (English and Spanish)
- Must have knowledge in: Process Validations Equipment Validations Equipment Qualifications Test Method Validations. Manufacturing Procedures generation Component Qualification QE experience with documentation reviewing and approving IQ OQ PQ.
- Technical Writing Skills
Ultimate Solutions Corp is an equal opportunity employer.
Employment Type
Full Time
Department / Functional Area
Key Skills
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