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Kedrion Biopharma is a biopharmaceutical company specializing in the development, production and distribution of plasma-derived products. Kedrion has been producing plasma products for over 40 years and has a market presence in about 100 countries. Our employees are committed to the highest standards and therapies for the patients and clinicians in hematology, immunology, neurology, and transfusion medicine.

The Senior Project Engineer provides project engineering for the Melville site with an emphasis on capital projects.

The Automation Engineer will be responsible for site-wide automation, developing, maintaining, and troubleshooting industrial control systems for formulation, filling, and packaging processes. This role leads to major projects, ensuring they meet company standards, stay on time and budget, and provides leadership during execution with both site employees and contractors.

Main Responsibilities:

• Technical Expertise: Serve as site expert for instrumentation and control systems, staying updated with current automation technology and company standards.

• Design & Installation: Specify, design, develop, install, commission, and qualify process control and automation solutions in direct support of manufacturing operations while adhering to company standards and regulatory expectations.

• Continuous Improvement: Identify opportunities for process optimization, reliability improvement, and cost reduction through automation.

• Project Management: Concurrently manage and execute or participate as a team member on multi-disciplined automation and controls capital and operating expense projects from inception to project completion in support of site operations insuring safety, regulatory compliance, company standards, operational requirements and business needs are met.

• Safety Commitment: Ensure personnel and process safety during operations and troubleshooting.

• Collaboration: Collaborate with cross-functional teams, including process engineers, validation specialists, and maintenance teams. Provide training to operations and maintenance personnel on control system functionalities.

• Programming: Configure and program Supervisory Control and Data Acquisition (SCADA), Programmable Logic Controllers (PLC), and Human-Machine Interface (HMI) systems.

• System Performance: Monitor and analyze process performance to identify areas for improvement.

• Documentation: Control and managing the documentation of automation processes, procedures, and specifications.

• Support: Provide technical support diagnosing and resolving automation systems issues in a timely manner. Provide 24/7 process controls/automation technical site support.

• Compliance: Ensure all automation systems comply with regulatory requirements, including cGMP (current Good Manufacturing Practice) standards, GAMP guidelines, and 21 CFR Part 11.

• Validation: Assist computer system validation with validation activities, including writing and executing validation protocols.

• Quality: Provide technical assistance to site quality systems through investigations, control system assessments, and corrective/preventative support to ensure a compliant GMP workplace.

Background and Experience:

• Bachelor’s degree in computer science, Engineering, or a related field, or suitable controls experience.

• Minimum 5 years, prior instrumentation/automation/control systems engineering experience in a cGMP regulated industry.

• Prior experience in the design, programming, start-up, or troubleshooting of industrial control systems, such as motion/servo controllers, variable frequency drives, PLCs, HMIs, SCADA, SQL databases and reports, industrial communication networks, process instrumentation, and up to 480V electrical control equipment.

• Familiarity with system qualifications, such as FAT/SAT, commissioning, and IQ/OQ validation.

• Familiarity with current GxP and NIH guidelines for biological and/or pharmaceutical processing, secondary manufacturing aseptic filling and packaging equipment, clean utilities, and HVAC systems.

• Also familiar with Building Automation Systems.

• Familiarity with relevant European and US regulatory requirements including GAMP guidelines, electronic records, and signatures (21 CFR Part 11), change control, validation.

Additional Skills:

• Self-starter with the ability to work independently in complex situations.

• Leadership skills to generate options, resolve problems, and prioritize solutions.

• Strong communication and interpersonal skills to interact with all organizational levels.

• Strong business understanding and team player mindset.

• Attention to detail, accuracy, and a quality-first mindset.

• High integrity while managing multiple priorities.

• Excellent computer and networking skills.

• Strong troubleshooting and root cause analysis capabilities.

• Proven ability to evaluate and optimize automation systems.

• Familiarity with IT applications supporting manufacturing technology and data flow.

Kedrion Biopharma offers a number of benefits to qualifying employees, including:

- Medical, vision and dental insurance

- Life and AD&D insurance

- Paid holidays

- PTO accrual

- and much more!

Please let us know if you would like further details regarding the benefits that we offer to our qualifying employees, and we would be glad to provide you with our full benefits guide, as well as answering any questions you may have!

Please be advised that our organization participates in E-verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. For more information on E-verify, please contact the Dept. of Homeland Security.

Please note that salary ranges are calculated based off levels of: relevant experience, education and certifications.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status.