Engineer, Technical Operations Process

Location

Greenville, SC | United States

Job description

This role is instrumental in advancing manufacturing operations by providing specialized technical support in key areas such as documentation, process controls, materials, formulation, and environmental conditions. This pivotal role is dedicated to enhancing quality, reducing costs, optimizing efficiency, and ensuring the seamless manufacturability of formulas. Key responsibilities include reviewing manufacturing processes and materials, troubleshooting formula-related issues, and staying abreast of industry innovations to capitalize on emerging technologies.

• Provide frontline technical support for designated departments, offering timely expertise and assistance.
• Cultivate a culture of continuous improvement by evaluating and recommending enhancements in quality and efficiency across process, engineering, and formulation domains.
• Uphold strict confidentiality regarding research, product development, trade secrets, regulatory matters, and strategic quality initiatives.
• Assess formulations to enhance manufacturability and efficiency, ensuring alignment with operational objectives.
• Remain informed about industry advancements to harness new technologies for operational enhancement.
• Foster cross-departmental teamwork to streamline operations and optimize outcomes.
• Lead the design and execution of process and yield improvement studies for underperforming products, employing advanced problem-solving skills to address complex challenges.
• Play an active role in investigations prompted by process deviations, CAPAs, audit observations, manufacturing exceptions, and trend analysis data. Develop and implement immediate corrections, as well as short and long-term solutions, adhering to change control procedures.
• Analyze supplier performance, material data, and product trends to identify opportunities for quality improvement and operational efficiencies.
• Ensure adherence to established Quality policies, procedures, and regulatory requirements in manufacturing instructions.
• Initiate Master Change Requests (MCRs), edit Master Batch Records (MBRs), Formula A-Pages, and generate deviations as necessary.
• Maintain accurate technical data and documentation related to trials and technical support activities.
• Prepare comprehensive communication and presentations to report issues, proposals, status updates, and results of process and formulation improvements.
• Update documents to the latest revision and format as required.

Skills and Abilities

• Thorough understanding of FDA/cGMP regulations and documentation practices.
• Proficiency in ERP systems, with experience in Oracle being advantageous.
• Knowledge of Lean or Six-Sigma methodologies for process optimization.
• Strong grasp of general science, chemistry, and physics principles.
• Proficient in mathematical calculations for formulations and cost approximations.
• Skilled in experimental design and statistical analysis to drive informed decision-making.
• Exceptional problem-solving abilities with a creative approach to challenges.
• Excellent written and verbal communication skills.
• Strong interpersonal skills to foster collaboration across teams.
• Ability to work autonomously with minimal supervision.
• Demonstrated leadership skills, even in the absence of formal authority.

• Bachelor's degree in Engineering, Chemistry, Biology, Pharmacy, or a related field.
• Minimum of 3 years' experience in technical operations engineering or a relevant role.
• Strong team player with outstanding problem-solving capabilities.
• Proficiency in MS Word, Excel, and PowerPoint for effective documentation and reporting.
• Organizational, communication, and analytical skills essential for success in the role.

Job tags

Salary