Pinnaql is a trusted consulting partner to regulated life sciences companies, providing deep technical, validation, and quality expertise across every stage of the product lifecycle. We partner with pharmaceutical, biotech, and medical device organizations to navigate complexity, accelerate project timelines, and maintain a strong state of compliance and audit readiness.
We are seeking an experienced Senior Process Engineer capable of independently executing and driving deliverables related to manufacturing process characterization, machine vision implementation, equipment qualification, process validation, technical documentation, and continuous manufacturing support within a regulated environment. This in an onsite position at a client site in Nicholasville, KY and will support multiple strategic projects and manufacturing initiatives.
Description:
- Process Engineering & Manufacturing Support
- Characterize process capability, assess Key Process Input Variables (KPIVs) and Key Process Output Variables (KPOVs), and evaluate controls
- Engineering studies/DOE to support process improvements and manufacturing objectives
- Root cause investigations and implementation of corrective actions Cross-functional collaboration with Manufacturing, Operations, Engineering, Maintenance, and Quality teams
- Machine Vision & Artificial Intelligence Machine vision system development and deployment for dimensional inspection and defect detection
- Application of AI and machine learning for image classification, anomaly detection, and process monitoring
- Camera, lighting, optics, and image-processing optimization
- Engineering studies to establish system capability, reliability, and inspection limits Qualification and validation of machine vision and AI-based inspection systems Qualification & Validation
- Support Development and execution of IQ, OQ, and PQ protocols Equipment qualification for new and existing systems
- Process validation planning, execution, and reporting Management of protocol deviations, exceptions, and associated investigations
- Change control assessments and implementation support Development of validation summary reports and final project deliverables
- GMP Documentation Development - Author, revise, and support approval of documentation including: Technical documentation, risk assessment, and change control support
- Process Evaluation Reports Process Characterization Protocols and Reports P
- rocess Validation Protocols and Reports
- Equipment Qualification Documentation
- User Requirements and supporting qualification documentation as required
Qualifications:
- Minimum 5 years of Process Engineering, Machine Vision, Validation, Manufacturing Engineering, or related experience
- Experience within Medical Device, IVD, Diagnostics, Biotechnology, Pharmaceutical, or other FDA-regulated manufacturing environments
- Demonstrated experience with Machine Vision and Learning Experience performing process characterization and process validation activities
- Experience supporting equipment qualifications and system verification activities
- Strong understanding of GMP requirements and regulated documentation practices
- Strong technical writing and documentation skills
- Ability to independently drive project deliverables and interact effectively across multiple functional groups
At Pinnaql, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.
Excited to build something meaningful together? We look forward to hearing from you.
Pinnaql is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.
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