Process Engineer

Join Knoa Pharma Knoa Pharma is a public health-driven pharmaceutical company dedicated to addressing the opioid crisis. Our focus is on expanding access to lifesaving overdose reversal medicines and affordable treatments for opioid use disorder. Owned by a not-for-profit foundation, everything we do is centered on improving public health, saving lives, supporting recovery, and bringing forward medicines that make a meaningful difference. Knoa Pharma has a robust generics and branded portfolio of medicines in development to address unmet medical needs, and it supports public health initiatives to address the opioid crisis. Its public health-minded purpose enables the company to expand access to lifesaving opioid overdose reversal medicines and affordable treatments for opioid use disorder - at no profit. Position Summary The Process Engineer provides engineering ownership and technical expertise for packaging equipment, automation systems, human-machine interface (HMI), and serialization solutions used in Oral Solid Dosage (OSD) pharmaceutical manufacturing. This role ensures reliable, compliant, and efficient packaging operations while meeting global serialization and data integrity regulations. The engineer collaborates cross functionally to support daily operations, projects, validation, and continuous improvement initiatives. Core Responsibilities Packaging Equipment Engineering Provide technical support and ownership for OSD packaging equipment, including bottle lines, bundlers, bundler labelers, case packers, labelers, checkweighers, and vision systems. Troubleshoot mechanical, electrical, and controls related issues to minimize downtime and improve line performance. Support equipment installation, commissioning, factory acceptance test/site acceptance test (FAT/SAT), and start up activities. Automation & HMI Support Support programmable logic controller (PLC), HMI, and supervisory control and data acquisition (SCADA) systems associated with packaging lines. Configure and maintain HMI screens, alarms, recipes, and user access levels. Troubleshoot controls and automation issues, working closely with maintenance and automation teams. Support automation upgrades, obsolescence management, and standardization initiatives. Serialization Provide engineering support for serialization and aggregation systems to ensure compliance with Drug Supply Chain Security Act (DSCSA). Support integration between packaging equipment, vision systems, serialization software, site repositories, and enterprise systems. Manage serialization exceptions, rework processes, aggregation hierarchy issues, and data reconciliation. Ensure data integrity and secure handling of serialized information. Qualification & Validation Develop, execute, and support installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) activities for packaging equipment, automation systems, and serialization solutions. Support change controls, risk assessments, and re validation activities related to equipment or software changes. Ensure validation documentation is accurate, compliant, and inspection ready. Compliance & Documentation Ensure packaging, automation, and serialization activities comply with cGMP, data integrity, and company quality standards. Author and review standard operating procedures (SOPs), user requirement specifications (URSs), functional specifications, validation documents, deviations, and corrective and preventative actions (CAPAs). Support internal audits, customer audits, and regulatory inspections. Continuous Improvement & Projects Identify and implement improvements to packaging line efficiency, automation reliability, HMI usability, and serialization performance. Support or lead capital and improvement projects related to packaging equipment, controls, and serialization upgrades. Apply lean manufacturing and operational excellence principles. Cross Functional Collaboration Partner with Manufacturing, Quality, Validation, IT/Automation, and Supply Chain teams. Provide technical training and support for operators and maintenance personnel. Interface with equipment vendors, automation providers, and serialization vendors. Education and Experience Bachelor's degree in Mechanical, Electrical, Automation, Industrial, or Chemical Engineering, or a related discipline. Associates degree will be considered with appropriate experience. 6-9 years of engineering experience in pharmaceutical packaging operations, preferably in an OSD environment. Hands on experience with packaging equipment and line integration. Knowledge, Skills and Abilities Ability to work with and support automation systems, including PLCs and HMIs. Ability to support serialization and aggregation systems in regulated environments. Knowledge of and ability to work in compliance with cGMP requirements. Knowledge of pharmaceutical packaging operations and associated equipment. Ability to apply industrial automation concepts, including PLCs and HMIs. Working knowledge of serialization regulations, data integrity principles, and track-and-trace systems. Strong ability to troubleshoot issues and perform root cause analysis. Ability to support change control, deviation management, and CAPA activities. Ability to communicate effectively through technical writing, verbal communication, and teamwork. Physical and Environmental Requirements Occasionally move/traverse, ascend/descend step ladders, stairs, and/or platforms. Wear appropriate Personal Protective Equipment including PAPR (Powered Air Purifying Respirator). Position requires wearing a Powered Air-Purifying Respirator (PAPR) during specific processes. Occasionally, transport materials using manual and power assisted vehicles including manually pushing and pulling drums, totes, boxes, and pallets. Perform cleaning and assembly/disassembly on production equipment which may require pulling, pushing, or twisting to remove equipment shields, parts, and panels. Equipment and parts may weigh up to 50 pounds. Ability to work a 10.5-hour per day, 4-day work week (Monday-Thursday), totaling 40 hours per week with off-shift, weekend, or shutdown support as required. Supervisory Requirements (if applicable) This position may provide functional guidance, project leadership, or mentoring to team members but does not have direct supervisory responsibility. Additional Information This job description is not intended to be an all inclusive list of duties and responsibilities and may be modified as business needs require. We are an Equal Opportunity Employer. Qualified applicants will receive consideration without regard to: actual or perceived race, sex or gender (including pregnancy, childbirth, lactation and related medical conditions), national origin, ancestry, citizenship status, religion, color, age, creed, sexual orientation, marital status, gender identity or gender expression (including transgender status), protected medical condition as defined by applicable state or local law, genetic information, physical or mental disability, veteran status and military service, or any other characteristic protected by local, state, or federal laws and ordinance. For more information about your rights under Equal Employment Opportunity, visit: EEOC Know Your Rights USERRA Rights Family and Medical Leave Act (FMLA) Employee Polygraph Protection Act (EPPA) E-Verify (English and Spanish) Right to Work (English and Spanish) We strive to make our Career opportunities website accessible to all users. If you need an accommodation to participate in the application or hiring process, please email the Knoa Pharma LLC Talent Acquisition team at careers@pharma.com. This email is not for general employment inquiries or vendors; rather it is strictly for applicants who require assistance. The Company does not seek or accept unsolicited resumes or CVs from recruitment agencies. We are not responsible for any fees, commission, or any type of payment related to unsolicited resumes or CVs except as required in a written agreement between the Company and the recruitment agency or party requesting payment of a fee. Under certain state law, we may be required to provide a reasonable estimate of the salary range for the jobs covered by this description. Actual salary determinations will take into account factors such as work location, prior education or training and experience, job related knowledge, and demonstrated skills aligned with the Company's internal leveling guidelines and benchmarks. Resumes may be considered in the order they are received.