Process Engineer

Job Description: client leading provider of global clinical supply chain. With an unwavering commitment to service, science and process engineering,  Clinical Services is powered by people with an exceptional commitment to quality, deeply instilled ethics of personal responsibility and unrivaled expertise. We are exclusively focused on serving the packaging and distribution requirements of clients across the world. Whether planning, packaging, labeling, storing, or distributing important supplies, Fisher Clinical Services has been committed to delivering the highest possible value while ensuring alignment to the highest level of quality, performance, reliability and sustainability standards.
Location/Division Specific Information
cleint run's the World's largest clinical packaging operation. Our Clinical Trials facilities are strategically placed around the world to accommodate local and regional sourcing needs. Join us to help serve millions of our global clinical trials patients!
How will you make an impact?
The Process Engineer will mentor and support in the diagnoses and resolution of software, instrument, and process problems to maintain system readiness of both manufacturing packaging equipment and data historian network. You will ensure site compliance and all vital activities are performed on time to keep equipment in working status.
What will you do?
As a member of the Engineering team you will provide daily support to the Packaging Operations Department with continuous improvement projects, machine solving, and onboarding of assets and new technology.
Core Responsibilities
• Identify, define, and action long-term continuous improvement projects through partnership with the site leadership and Operations team.
• Evaluate process improvements to reduce cost, improve efficiency, and improvement quality.
• Identify, evaluate, and implement process improvement methods for improving worker efficiency, reducing cost, and reducing waste of materials and utilities such as restructuring job duties, reorganizing workflow, relocating workstations and equipment, and purchase of new equipment / technology.
• Lead multiple project engineering driven assignments and the associated project schedules, from start to finish with sound project management methodologies.
• Collaborates with Production to modify workflow barriers and arrangements to increase throughput.
• Evaluates and drive engineering project initiatives to reduce setup time, increase machine speeds, reduce labor hours, reduce reject rates, and improve quality.
• Provide technical specifications and supporting documentation for Engineering project designs, and machine upgrades.
• Complete deviation investigations, change controls and corrective/preventative actions.
• Review and approve Engineering and Validation documents.
• Serve as site system administrator for all automated equipment and routine maintenance
How will you get here?
Education
Bachelor of Science Degree in Packaging, Mechanical, Industrial, Electrical Engineering or another scientific subject area from an accredited College or University required
Experience
5 Years Engineering experience in relevant GMP, pharmaceutical or food industry required
Knowledge, Skills, Abilities
• Experience with designing, programming, modeling, and testing of automated systems including robotics and clinical packaging equipment to ensure code and configurations meet specifications and validation requirements strongly preferred.
• Prior experience working within GAMP 5 and GMP environments strongly desired.
• Ability to configure process control system software and recipes and collect/format process data to support production or quality department requests.
• Well versed in process improvement, industrial design applications that pertain to a job shop environment.
• Experience with blister machines, bottling, carding, labeling, and syringe assembly preferred.
• Must be results oriented and comfortable training, mentoring, and coaching peers and multi-functional team members.
• Possess analytical skills in Lean Manufacturing, Six Sigma, and Single¬ Minute Exchange of Dies (SMED) to enhance quality, reduce rejects, and streamline processes.
• Experience with failure analysis and reliability engineering preferred.
• Have strong technical writing skills with experience writing Requirement Specifications (Design, Functional, User), FMEAs, FAT/SAT/Commissioning Protocols, SOPs and Work Instructions desired.
• Experience with PLC Automation control system start-ups, loop tuning, solving, and control system modifications is desired
• Experience developing sophisticated process control applications applying a mixture of programming formats including sequential function charts, function blocks and PLC ladder logic preferred