QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.
Responsibilities:
- Generate, execute process validation plan and reports [PV: characterization, OQ, PQ] (not cleaning processes) and equipment qualification [CSV: URS, FAT, IQ, OQ, PQ, TMV] (not laboratory)
- Provides technical and sustaining engineering support in a manufacturing area.
- Recommends and implements equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques as well as production yields for existing products.
- Integrates equipment and material capabilities to meet process module target specifications and technology target specifications.
- Reviews product development requirements for compatibility with processing methods to determine costs and schedules.
- Interacts with product design and development personnel to ensure that processes and designs are compatible.
- May develop and conduct statistical analysis or recommend additions to document work.
- Leads the innovation, development and/or optimization of new manufacturing concepts, processes and procedures for transfer to manufacturing operations.
- This can include scouting and feasibility work, material selection, process and equipment selection, tooling fixture and equipment installation and assessment of inputs, outputs and alignment to requirements.
- Develops manufacturing processes that are applicable to statistical process control and may develop those techniques including the measurement systems.
- Ensures processes and procedures are in compliance with regulations.
Qualifications:
- Bachelor's degree in Mechanical, Biomedical, Industrial or Chemical Engineering
- 3+ years in validation experience
- Availability to work first and / or second shift (If require) mainly first shift
Skills Required
- Bachelor's degree in Mechanical, Biomedical, Industrial, or Chemical Engineering
- 3+ years of process validation experience
- Experience with process validation and equipment qualification (PV: characterization, OQ, PQ; CSV: URS, FAT, IQ, OQ, PQ, TMV)
- Availability to work first and/or second shift (primarily first shift)
What We Do
The Quality Consulting Group is a pharmaceutical, biotechnology, food and medical device specialty consultant that supports the manufacturing industry; services are provided in multiple areas including: Regulatory Compliance, Quality Operations, Validation, Manufacturing, Training and Technical Support. Starting, as individual services provider since 2002, Quality Consulting Group has supported clients implementing the latest standards such as Validation Guidance, ICH Guidelines, and Process Excellence and Risk Management tools. Quality Consulting Group has provided expertise in such areas as: business, operational, quality, regulatory and manufacturing strategies; organizational structures; management controls; manufacturing and quality systems methodologies and practices; compliance programs; and accuracy reviews; FDA, EMEA and other regulatory matter
