At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.
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Job Summary
The Process Engineer - Packaging is responsible for optimizing manufacturing performance by coordinating production trials, validating process changes, and ensuring improvements are effective, sustainable, and aligned across the entire production process. Acting as a technical expert, this individual evaluates how equipment, systems, and technologies interact, identifying opportunities and resolving obstacles to keep production lines running smoothly, efficiently, and in harmony. The Process Engineer - Packaging develops and maintains technical documentation, standardizes best practices, and supports Continuous Improvement initiatives through the application of Lean and Six Sigma methodologies. Additionally, the role analyzes production metrics such as OEE, downtime, and waste using tools like Excel, Power BI, and MES systems to drive data-based decisions, performance reporting, and visual management practices.
On-Site Expectations
- 100% on-site position.
- 1st Shift: Monday - Friday, 8:00am - 5:00pm.
Responsibilities
Process Validation & Production Optimization
- Coordinate and execute production trials, machine tests, and process improvement initiatives.
- Validate process changes to ensure improvements are effective, sustainable, and meet performance objectives.
- Analyze production workflows to identify inefficiencies, bottlenecks, and opportunities for optimization.
- Troubleshoot technical issues and support solutions that improve line efficiency, reliability, and throughput.
Technical Systems Integration & Manufacturing Support
- Evaluate how production equipment, automation, and technologies interact across the manufacturing process.
- Optimize machine settings and process parameters to ensure equipment operates efficiently and in harmony.
- Identify and resolve obstacles between interconnected systems that impact production performance.
- Support the implementation of new equipment, technologies, and process enhancements.
Continuous Improvement & Performance Management
- Lead and support Continuous Improvement initiatives using Lean Manufacturing and Six Sigma methodologies.
- Collect and analyze production metrics, including OEE, downtime, waste, and efficiency data.
- Utilize tools such as Excel, Power BI, and MES systems to monitor trends and drive data-based decisions.
- Support visual management practices through KPI tracking, reporting, and daily performance reviews.
Documentation & Standardization
- Create, maintain, and update technical documentation, including process parameters, changeover procedures, and technical standards.
- Develop standardized processes and best practices to improve consistency and operational performance.
- Ensure technical knowledge and process improvements are effectively documented and shared across teams.
- Support compliance with established manufacturing standards and continuous improvement objectives.
Qualifications
- Bachelor's degree in Engineering required, with a minimum of 4 years of engineering project planning and/or project management experience.
- At least one year of working in a Pharmaceutical cGMP evironment is required for consideration.
- Previous experience in a sterile manufacturing environment is preferred.
- Experience in a pharmaceutical cGMP manufacturing, packaging, OSD, or sterile setting required.
Knowledge, Skills, and Abilities
- Demonstrated ability to evaluate complex manufacturing processes, solve technical problems, and make data-driven decisions in dynamic production environments.
- Strong analytical skills, including the ability to perform complex mathematical calculations, analyze data trends, and interpret graphs, charts, and technical information.
- Excellent verbal, written, and presentation skills, with the ability to communicate effectively and collaborate across all levels of the organization.
- Proficiency in Microsoft Office applications, including Word, Excel, and PowerPoint.
- Ability to interpret written, verbal, diagrammatic, and schedule-based instructions while consistently executing work in accordance with established procedures and timelines.
- Demonstrated commitment to maintaining a safe, clean, and organized work environment while adhering to all company policies, regulatory requirements, and quality standards.
- Proven ability to work collaboratively across functions, build strong working relationships, and leverage the expertise of others to achieve business objectives.
- Strong leadership capabilities, including strategic thinking, decisive decision-making, performance accountability, continuous learning, and a passion for delivering value to customers.
- High level of integrity and professionalism, with a commitment to ethical conduct, customer focus, operational excellence, and a "first-time-right" mindset.
Physical Demands and Work Environment
The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to sit. The employee is occasionally required to stand; walk and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
While performing the duties of this job, the employee is frequently exposed to moving mechanical parts, fumes, or airborne particles and toxic or caustic chemicals. The employee is occasionally exposed to wet and/or humid conditions; high, precarious places, risk of electrical shock and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, hearing protection, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc. Other tasks involving elevated work may require the use of a body harness and lanyard. Additionally, the employee may be required to operate an industrial vehicle.