Process Engineer II jobs in United States
cer-icon
Apply on Employer Site
company-logo

PCI Pharma Services · 1 week ago

Process Engineer II

PCI Pharma Services is dedicated to life-changing therapies with a global impact. The Process Engineer II role focuses on floor operations and eliminating waste to ensure high-quality product production, providing technical leadership for new product launches and leading continuous improvement activities.

BiotechnologyHealth CareLife ScienceMedical DevicePackaging ServicesPharmaceutical
check
H1B Sponsor Likelynote
Hiring Manager
Kerry Harper
linkedin

Responsibilities

Identify and mitigate packaging issues for existing business through strong engineering and process improvement methods
Provide technical leadership for new product launches
Lead continuous improvement activities
Specify, purchase, and commission new equipment and manage capital finances
Provide technical support for new business (Sales/Business Development Support)
Analyzes sales requests to determine equipment, tooling, or delivery systems needed
Performs Engineering review of all components for new jobs (size, capability of equipment, bar codes)
Applies sound engineering principles to design new equipment, production lines and component layout, with a goal of designing a process capable of low defects (less than 1%), high uptime (greater than 95%), low waste (less than 1%), and throughput better than estimate
Conducts and/or participates in customer meetings and attends occasional off-site meetings
Interacts with Sales and customers to determine requirements for new products/orders
Participates in internal review meetings to plan new jobs with plant Operations, Maintenance, Quality, Purchasing and Process Engineering
Prepares SOPs, line layouts, production line diagrams as needed
Specify, order, and commission tooling as required for launch activities
Responsible for the administration, implementation, and project management of assigned projects, including using standardized methodology
Research new trends and technologies in packaging; evaluates and tests new equipment and processes
Coordination of outside design, integration, and equipment manufacturing services
Work with staff on development of new equipment performance requirements
Assist Validation with OQ and PQ (Operational and Process Qualifications) of new packaging business
Write and modify SOPs relating to the production area and assist in training of affected personnel
Leads CAPA (Corrective and Preventative Actions) investigations and actions
Initiate investigation activity and troubleshoot problems in packaging; discovers causes of non-conformance, i.e., slow throughput, poor quality and/or unsafe design
Writes and executes engineering protocols as needed
Uses DOE (Design of experiments) to control variables while testing
Applies sound engineering principles to improve existing equipment, packaging design and processes by reducing waste, increasing throughput, reducing energy consumption or eliminating human interaction through automation
Facilitates cross-functional Lean Six Sigma process improvement teams using a DMAIC method
Responsible for the administration, implementation, and project management of new business, including conformance with customer requirements and equipment / process performance criteria
Measure and analyze performance metrics of the production area and spearhead initiatives to decrease variability and waste

Qualification

Lean Six SigmaPharmaceutical PackagingProject ManagementEngineering PrinciplesCGMP KnowledgeIndustrial Production EquipmentMulti-taskingMicrosoft OfficeAutoCADMicrosoft ProjectVisioEffective CommunicationProblem SolvingLeadership QualitiesDetail Oriented

Required

Bachelor of Science in Engineering or equivalent required
3-7 years relevant engineering experience
Familiarity with general industrial production equipment
Effective communication skills (verbal and written form)
Effective at leading project teams and interfacing with customers and operations personnel
Ability to prepare a project plan
Must possess and demonstrate motivational and leadership qualities
Must possess excellent problem solving and analytical skills
Must be well organized along with being detail and multi-task oriented
Fully competent in the use of computer software – Microsoft Windows, Microsoft Word, Microsoft Excel and Microsoft Power Point
Ability to use Microsoft Project, Visio, and AutoCAD

Preferred

Lean Six Sigma Background preferred
Pharmaceutical and/or food packaging background preferred
Familiarity with pharmaceutical packaging equipment such as Blister, Pouch, Bottle, Tablet Feeding, Carton and Carding machinery is highly desirable
Knowledge and experience in cGMP are desirable
Knowledge of Lean and / or Six Sigma is a plus

Company

PCI Pharma Services

company-logo
PCI Pharma Services is a provider of outsourced services to the global pharmaceutical market.

H1B Sponsorship

PCI Pharma Services has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
2020 (2)

Funding

Current Stage
Late Stage
Total Funding
unknown
2025-07-14Series Unknown
2020-08-24Acquired
2014-08-10Seed

Leadership Team

leader-logo
Gil Valadez
Chief Operating Officer
linkedin
Company data provided by crunchbase