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Engineering Officer KriGen Pharmaceuticals LLC d/b/a Dynamic Biologics Lillington, NC Job Details Full-time 2 days ago Benefits Health insurance Dental insurance Paid time off Vision insurance Qualifications Industrial automation Project engineering Mechanical Engineering CAD design (engineering design task) Engineering process optimization Equipment troubleshooting Project management experience in manufacturing Pharmaceutical company experience Quality assurance experience within pharmaceutical industry Regulatory/legal compliance standards in production Managing projects Technical troubleshooting support Quality improvement programs in engineering Mechanical troubleshooting Cross-functional communication FDA regulations Pharmaceutical manufacturing facility experience

Full Job Description Position Summary:

We are seeking a highly skilled and experienced Engineer to join our dynamic engineering team. The Engineer will play a critical role in designing, optimizing, and maintaining pharmaceutical engineering systems, ensuring compliance with regulatory requirements, and driving continuous improvements across processes and technologies. The ideal candidate will possess a deep understanding of pharmaceutical manufacturing and engineering principles, coupled with the ability to work in engineering and maintenance team.

Key Responsibilities:

Ø Work in engineering projects related to the design, modification, and optimization of Utilities, systems and equipment. Ø Responsible for preparation and review of Standard Operating Procedures (SOPs) for engineering, maintenance and repair processes. Ø Support the installation and commissioning of new process equipment Ø Perform Validation & Qualification of Utility Systems (e.g. HVAC System, Water System, Nitrogen, Compressed Air) Ø Execute preventive maintenance schedules for machines and equipment. Ø Conduct preventive, predictive, and breakdown maintenance on critical pharmaceutical machinery (e.g., Filling Lines, Autoclaves, Terminal sterilizer, HVAC, Water Systems etc) Ø Maintain maintenance records and checklists. Ø Ensure that all plant and machinery is repaired promptly online. Ø Prepare calibration schedule and ensure calibration activities completed as per schedule. Ø Prepare building maintenance schedule and execution as per plan. Ø Participate in training and technical support when required. Ø Participate in risk assessments and Failure Mode Effects Analysis (FMEA) on systems and processes to identify potential risks and implement improvements. Ø Collaborate with cross-functional teams to develop and implement innovative engineering solutions Ø Ensure all systems, processes, and equipment comply with FDA, cGMP, and other regulatory standards. Ø Prepare and review documentation for regulatory submissions, including qualification/validation reports and standard operating procedures (SOPs). Ø Coordinate the implementation of change controls, CAPAs (Corrective and Preventive Actions), and other quality initiatives. Ø Stock of spares is maintained and advising on spares that are required Ø Continuously monitor and improve key process parameters to maintain product quality and regulatory compliance. Ø Collaborate closely with Quality, Manufacturing, and Supply Chain departments to drive seamless integration of new technologies and processes. Ø Provide technical expertise and support during investigations, audits, and inspections. Ø Ensure effective communication of technical information to both technical and non-technical stakeholder.

Qualifications:

Ø Bachelor's or Master's degree in, Mechanical Engineering, Pharmaceutical Engineering, or a related field.

Experience:

Ø minimum of 3-5 years of experience in pharmaceutical engineering or a related field. Ø In-depth knowledge of pharmaceutical manufacturing processes, equipment, and cGMP regulations. Ø Proven experience in project management, process optimization, and cross-functional collaboration. Ø Strong background in equipment qualification, validation, and troubleshooting.

Skills:

Ø Expertise in process control systems, manufacturing equipment, and automation technologies. Ø Advanced knowledge of engineering tools such as AutoCAD software Ø Experience with mid/large-scale pharmaceutical manufacturing or aseptic processing is a plus. Ø Knowledge of Lean Manufacturing and/or Six Sigma methodologies. Ø Ability to work in a regulated environment with strict adherence to safety, quality, and compliance standards. Ø Works as a member of a team to achieve all outcomes. Ø Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements. Ø Performs all work in support of our

Values:

Collaboration, Courage, Perseverance, and Passion. Ø All other relevant duties as assigned.

Benefits:

Dental insurance Health insurance Paid time off Vision insurance Application Question(s):  Bachelor's or Master's degree in, Mechanical Engineering, Pharmaceutical Engineering, or a related field.

Work Location:

In person