Process Engineer 1

SHL Medical; Deerfield Beach (FL); On-site; USD 60,000 - 80,000; Full time

Benefits offered by this job

Competitive compensation package

Modern working environment

Challenging assignments

International team experience

Professional development opportunities

Job summary

A leading provider of drug delivery systems is seeking a Process Engineer to support the implementation of new processes into manufacturing. Responsibilities include drafting documentation, supporting design transfer, and performing troubleshooting. Candidates should possess a B.S. in Biomedical or Mechanical Engineering and have familiarity with FDA and ISO guidelines. This full-time role offers competitive compensation and development opportunities in an innovative industry.

Qualifications

• 0-2 years of experience within the medical device industry is preferred.
• Familiarity with FDA and ISO practices is required.
• Must have practical experience in mechanical design principles and manufacturing processes.

Responsibilities

• Support design transfer for product assembly and packaging.
• Support new production equipment design and qualification.
• Draft documentation for system validation.
• Perform troubleshooting and root cause analysis.
• Identify opportunities for continuous improvement.

Skills

Biomedical Engineering

Mechanical Engineering

FDA Guidelines

ISO Standards

Good Laboratory Practice

Good Manufacturing Practices

Microsoft Excel

Microsoft Word

Effective Communication

Collaboration

Education

B.S. in Biomedical Engineering/Mechanical Engineering

Job description

Process Engineer 1

Process Engineers are responsible for supporting the implementation of new process systems into manufacturing production while ensuring that all activities are completed and documented by SHL Pharma Quality System requirements. Serving as the voice of operations between the development site and manufacturing site, the Process Engineer will be responsible for supporting the design, development, testing, and evaluation of assembly, labeling, packaging, and serialization operations.

Execute Manufacturing Sciences (MS) Project activities under the guidance of MS Senior Process Engineers/MS Principal Process Engineers and MS Manager.

Job Overview

SHL Medical is the world‑leading solution provider in the design, development, and manufacturing of advanced drug delivery systems with more than 5000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto‑injectors or pen injectors to effectively deliver their drugs. Headquartered in Switzerland since late 2018, with sites in Sweden, Taiwan, and the United States.

Main Responsibilities

• Support design transfer, specifically the final assembly, labeling, packaging, and serialization of products as they hand‑off from development to commercial launch.
• Support the design, qualification, and implementation of new production equipment.
• Draft and update 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 documentation for computerized system validation (CSV) including Functional/Design Specifications, Design Qualification (DQ), Functional Risk Assessment (FRA), Requirements Traceability Matrix (RTM), etc.
• Draft and execute Validation Project Plans (VPP), Validation Final Reports (VFR), and periodic 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).
• Document MS activities to support the MS Key Performance Indicators (KPI) tracking.
• Perform troubleshooting and root cause analysis with a cross‑functional team to conduct investigations, Non‑conformance Reports (NCR), Corrective and Preventive Actions (CAPA), etc.
• Serve as the second line of support after Manufacturing Engineering (ME) to Manufacturing (MFG).
• Provide training on production equipment to ME and MFG personnel.
• Identify opportunities for continuous improvement in MS and support the execution and implementation of LEAN projects.
• Support and conduct customer complaint investigations.
• Support or lead machine shop activities.
• Comply with all quality, safety, and industry regulations.

Skills And Qualification

• B.S. in Biomedical Engineering/Mechanical Engineering or any relevant branch of study is preferred.
• 0-2 years of experience within the medical device industry is preferred.
• Familiarity with industry practices and guidelines including those outlined by the FDA and ISO is required.
• Knowledge of Good Laboratory Practice (GLP), Good Manufacturing Practices (GMP), and Good Documentation Practices (GDP) is required.
• Must have practical experience and a solid understanding of mechanical design principles, testing, and manufacturing processes.
• Proficiency in Microsoft Excel and Microsoft Word is required.
• Effective communication (written and verbal) and collaboration within cross‑functional teams are required.

Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

Physical Requirements

• While performing the duties of this job, the employee is regularly required to use hands to handle or feel objects, tools, or controls; reach with hands and arms; stoop, kneel, or crouch.
• Specific vision abilities required by this job include close vision, and the ability to adjust focus.

We Offer

• Competitive compensation package
• Modern working environment with state‑of‑the‑art facilities and technologies
• Challenging assignments in a fast‑growing and innovative industry
• Position in a dynamic, international team of highly skilled professionals
• Various opportunities for personal and professional development within a global organization

Seniority level

• Associate

Employment type

• Full‑time

Job function

• Management and Manufacturing

Industries

• Medical Device