GMP Pros is seeking a Packaging Engineer with direct centerlining expertise to support client packaging operations through our phased centerlining engagement model. This person must have direct, hands-on experience building centerlines, running DOEs, reducing changeover, and driving the cultural and operational disciplines that make centerlining stick. They should bring Lean or Six Sigma credentials and the ability to engage operators, maintenance, and supervisors at the floor level to deliver durable results for our clients.
APPLICANTS MUST HAVE PRIOR EXPERIENCE IN BIOTECH, PHARMACEUTICAL, OR ANIMAL HEALTH INDUSTRIES TO BE CONSIDERED
Essential Duties:
- Execute GMP Pros' centerlining methodology across all phases: scope and readiness (Phase 0), evaluate and define (Phase 1), refine and execute (Phase 2), and assess and solidify (Phase 3).
- Conduct equipment and process readiness assessments: inventory line count, machine count, mechanical and electronic adjustment points, changeover formats, and available performance data (OEE, downtime, changeover time).
- Perform Phase 1 documentation reviews: cross-reference OEM manuals, equipment SOPs, PM records, qualification documents, batch tickets, and work instructions to identify gaps and confirm equipment state.
- Conduct operator and maintenance interviews and on-floor observations to capture machine quirks, setup practices, undocumented knowledge, and current-state culture.
- Develop master adjustment lists identifying all process-critical adjustment points per machine and SKU, including mechanical and electronic settings with current and target values.
- Design and execute Design of Experiments (DOEs) for CPP confirmation - defining measurements, intervals, sample sizes, success criteria, and adjustment sequencing to optimize centerline parameters.
- Create centerline documentation: control plans, point-of-use labeling, SOP updates, and change management tracking forms aligned to client document systems.
- Drive changeover reduction using structured methods (SMED or equivalent): analyze current changeover procedures, identify waste and variability, and implement standard changeover SOPs with measurable improvement.
- Lead or support Phase 3 audit activities: review change controls, deviations, calibration schedules, training records, and adjustment point integrity; generate audit reports with findings and recommended corrective actions.
- Establish and facilitate centerline review cadences (weekly/bi-weekly) with client operations, maintenance, and engineering teams, covering OEE, changeover data, downtime trends, and centerline change review.
- Support identification and development of client-side centerline champions to sustain the program after GMP Pros' engagement concludes.
- Partner with QA, Maintenance, Operations, and Engineering to keep packaging lines controlled, compliant, and execution-ready in accordance with client GMP requirements.
Requirements:
- 5-10+ years of hands-on packaging engineering experience in a regulated or GMP-controlled manufacturing environment.
- Direct, demonstrated experience building centerlines on packaging lines - including adjustment point identification, parameter optimization through DOEs, master list creation, and control documentation. Not just familiarity with the concept.
- Proven track record of changeover reduction: structured approach, measurable before/after results, and ability to engage the floor team to develop and sustain standard changeover procedures.
- Experience designing and executing DOEs in a production packaging environment, including defining success criteria, managing data collection, and translating results into documented centerline settings.
- Strong troubleshooting capability on live packaging lines - comfortable diagnosing equipment, process, and setup issues in real time and working alongside operators and mechanics to resolve them.
- Comfort working on-site full time, with the majority of time spent on the production floor across multiple packaging areas.
- Bachelor's degree in Engineering (Mechanical, Industrial, Chemical, Packaging, or related discipline).
Preferred:
- Experience in a life sciences packaging environment - pharmaceutical, consumer health, OTC, or medical device packaging strongly preferred. Familiarity with GMP expectations for documentation, change control, and deviation management in a packaging context.
- Experience supporting or leading centerlining for multiple equipment types across a full packaging line - e.g., fillers, cappers, labelers, cartoners, blister lines, case packers, or serialization equipment.
- Familiarity with OEE analysis and the ability to tie centerline and changeover data to line-level OEE trends.
- Lean certification (Lean Practitioner, Lean Expert, or equivalent) and/or Six Sigma Green Belt or Black Belt.
- Experience with packaging line TPM programs, PM review and alignment to OEM recommendations, or reliability improvement work tied to packaging equipment.
- Exposure to packaging validation lifecycle activities (IQ/OQ/PQ, process validation, continued process verification) and understanding of how centerline parameters interact with validation boundaries and CQAs.
- Experience using plant systems such as SAP, MES, OSIsoft PI, or data visualization tools (Power BI, Tableau) to gather, analyze, and present packaging performance data.
- Experience with statistical tools such as Minitab or JMP for capability studies, control charting, and DOE analysis.
Pre-Employment Requirements:
- Pass and maintain pre-employment/contract background check and safety certification, including but not limited to outstanding professional references.
- Subject to motor vehicle report review.
- Maintain valid driver's license and endorsements as required per position.
- Pass pre-employment/contract physical, medical evaluation, and drug screen due to the safety sensitive nature of this position.
- Successfully complete and maintain any required safety certification and testing on an annual basis.
Work Environment Expectations
- This role is expected to be on-site full time at the client facility.
- The individual must be comfortable on the production floor throughout the day - observing equipment, working alongside operators and mechanics, capturing adjustment points, and executing DOEs during live production runs or scheduled trials.
- This is a hands-on technical engagement role. Preference for desk-based or remote support is not compatible with how GMP Pros delivers centerlining. The engineer is expected to be the most visible technical resource on the floor during the engagement.
