We are currently hiring permanent Permanent Process Engineer to be based in Southern Florida.
PTS Advance is excited to announce a new opportunity that supports one our leading clients that is globally recognized in the medical device industry. They are seeking a permanent Senior Process Engineer who will be responsible for the implementation of new process systems into manufacturing production while ensuring that all activities are completed and documented in accordance with Company Quality System requirements. Our client will only consider applicants in a full time, permanent, onsite (40hrs/wk) capacity.
Below is a list of the key responsibilities for the role, whilst not exhaustive, that you’ll need to be able to perform;
- Lead the design, development, testing, and evaluation of assembly, labeling, packaging, and serialization operations.
- Lead MS projects effectively to ensure major milestones are achieved on-time through appropriate resource planning and coordination, material and time management, timeline development, risk mitigation (e.g., foreseeing obstacles and identifying ways to avoid them or minimize their impact), escalation to the MS Manager, etc.
- Model leadership skills by taking extreme accountability/ownership for their own projects, as well as other MS projects as needed based on resource availability.
- Draft (right-first-time), update, and review Engineering Protocols (ENP) and Reports (ENR), Batch Records (BR), Bill of Materials (BOM), Technical Specifications (TS), Product Specifications (PS), Quality Work Instructions (QWI), Quality Operating Procedures (QOP), Quality Forms (QF), Templates (TEM), equipment design and qualification documentation (e.g., URS), pFMEAs, Change Controls, etc.
- Draft (right-first-time) documentation for computerized system validation including Functional Specifications, Design Specifications, Functional Risk Assessment (FRA), Risk Traceability Matrix (RTM), etc. in accordance with GAMP5.
- Execute and lead Validation Project Plans (VPP), Validation Final Reports (VFR), and periodic equipment qualification reviews, as well as protocols and reports for Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), commissioning, Installation Operational Qualification (IOQ), Performance Qualification (PQ), and Process Validation (PV).
- Perform root cause analysis and lead cross-functional teams to conduct investigations, Non-conformance Reports (NCR), Corrective and Preventive Actions (CAPA), etc.
Desirable applicants will hold a B.S. in Biomedical Engineering/Mechanical Engineering or related field with 7+ years of experience within the medical device industry. Proficient knowledge of industry practices and guidelines including those outlined by the FDA, ISO, OSHA, GAMP5, and ASTM. Expert understanding of Good Laboratory Practice (GLP), Good Manufacturing Practices (GMP), and Good Documentation Practices (GDP). Expert understanding of mechanical design principles, testing, and manufacturing processes, as well as DFM/DFA. Ability to lead teams effectively. Effective communication (written and verbal) and collaboration within cross-functional teams.
In return you will be offered the opportunity to join a market leading business who are at the forefront of cutting-edge technology, alongside a great package and career progression.
- Acceptance Testing
- Design Elements And Principles
- Design For Manufacturability (Industrial Design)
- Good Manufacturing Practices
- Industry Practices