Senior Engineer, Analytical Sciences, Deerfield Beach

We have an immediate opening for a Senior Engineer, AS, at our Deerfield Beach, Florida headquarters.

Our company provides final assembly, labeling, and packaging services of drug delivery devices to the pharmaceutical and biotechnology industries and soon clinical fill-finish capabilities. Scientists and Engineers work closely with our partners to continuously create and introduce innovative, patient-centric solutions to enhance patient compliance and user experiences. Dedicated project managers work closely with their partner company counterparts to develop and maintain program timelines in line with our partners? strategic and business needs. In addition, for those partners who wish to have SHL handle the final assembly process, SHL Pharma offers robust final assembly and labeling capabilities that enable our partners to improve speed to market and reduce the number of parties involved and have one clear point of responsibility.

Job Overview:

Lead Analytical Sciences (AS) projects designed to characterize and release medical devices. Provide expert support and performance when executing AS project activities. Mentor AS Engineers.

Main Responsibilities

• Lead AS 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 AS Manager, etc.
• Model leadership skills by taking extreme accountability/ownership for other AS projects as needed based on resource availability.
• Independently research problems to identify and propose potential solutions.
• Proactively update the AS Manager on project status and escalate issues early on to avoid delays.
• Draft (right-first-time), update, and review Engineering Protocols (ENP) and Reports (ENR), Stability Protocols (STP) and Reports (STR), Quality Work Instructions (QWI), Quality Operating Procedures (QOP), Quality Forms (QF), Templates (TEM), equipment design and qualification documentation (e.g., URS), Change Controls, etc.
• Operate AS lab equipment such as Instrons, JOHOs, vibration machine, environmental chambers, etc.
• Troubleshoot and improve AS software such as ST-ITE, Bluehill, etc.
• Draft, execute, and lead Test Method Development (TMD), Test Method Validation (TMV), Test Method Transfer (TMT), Container Closure Integrity Testing (CCIT), Robustness/Reliability Testing, Stability Testing, Transportation/ASTM Testing, etc.
• Support and lead the SHL Pharma Stability Program, including coordinating time point testing, preparing stability samples and material, etc., to ensure testing, protocols, and reports are completed according to project timelines.
• Record, report, analyze, and review test results against specifications per Good Documentation Practices (GDP).
• Document testing activities to support the AS Key Performance Indicators (KPI).
• Lead, track, and monitor AS KPIs.
• Perform root cause analysis and lead cross-functional teams to conduct Out of Specification (OOS) investigations, Non-conformance Reports (NCR), Corrective and Preventive Actions (CAPA), etc.
• Perform cleaning as well as corrective and preventive maintenance of AS lab equipment.
• Serve as the second line of support after Manufacturing Engineering (ME) to Quality Control (QC).
• Lead training on test systems and test methods to ME, AS, and QC personnel.
• Lead the design, qualification, and implementation of new AS and QC equipment, including design documentation (e.g., URS, RTM) and computerized system validation.
• Identify opportunities for continuous improvement in AS and lead the execution and implementation of LEAN projects.
• Participate in the Global Test Network.
• Lead and execute early development studies (e.g., feasibility studies), as needed.
• Support as an SME for health authority and regulatory bodies audits and inspections.

Skills and Qualification:

• B.E. in Biomedical Engineering/Mechanical Engineering or any relevant branch of study is preferred.
• 3-5 years of experience within the medical device industry is required.
• Understanding of industry practices and guidelines including those outlined by the FDA, ISO, and ASTM is required.
• Expert understanding of Good Laboratory Practice (GLP), Good Manufacturing Practices (GMP), and Good Documentation Practices (GDP) is required.
• Proficiency in Microsoft Excel and Microsoft Word is required.

The physical demands described here are representative of those that must be met by and employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 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 have an excellent benefits package and offer a salary that is based on experience and accomplishments. If you possess the required experience and qualifications and want the challenge of growing with our company, then submit your resume in confidence to our Talent Acquisition Department at