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Job Description

Position Title: Automation Engineer (Advanced Drug Delivery Devices)

Reports to: Engineering Director/Manager

FLSA Status: Exempt

Location: Philadelphia, PA

SUMMARY:

The main functions of an Advanced Drug Delivery Devices (ADDD) Automation Assembly Engineer are:

• Conceptualize manufacturing processes in support of new business opportunities (Sales/Business Development Support)

• Develop specifications (URS), manage assembly automaton build with selected vendor, participate in validation, and manage transition to sustaining product support,

• Serve as automation lead on NPI teams for new product launches

• Manage new equipment specification and build to established budget and timeline

The activities of the Automation Engineer are focused on bringing new equipment and product-specific equipment variants into the site. This includes working with the customers to define the specifications, capacity and flexibility requirements. Initial project activity includes writing the URS, leading the pFMEA effort, and working with the equipment supplier to monitor build progress. Upon build completion, FAT, SAT and full validation (IQ, OQ, PQ) are part of the role. A strong statistical background is required to be able to perform equipment DOEs, process optimization, MSAs and Cpk analysis. Transfer to production requires training and support of the teams, and ensuring a robust and safe production process is in place. This is achieved through individual effort and facilitation of teams, tracking and analysis of metrics, strong understanding and utilization of good engineering practices, project management, and the use of Lean Six Sigma techniques.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Management of the Equipment Acquisition and Validation Process Including:

• Specifies equipment needed (URS), prepares RFQs, and obtains quotes from vendors.

• Applies sound engineering principles to define URS, production line design, 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.

• Writes CER’s (Capital Equipment Requests) for new PCI-owned equipment, including researching the justification.

• Upon approval, negotiates, orders, and manages build of equipment meeting established budget and timeline.

• Participate in internal project review meetings with plant-wide leadership to prepare for successful launch.

• Write and execute protocols for FAT (Factory Acceptance Tests) and SAT (Site Acceptance Tests).

• Writes and executes the measurement system analysis including Gage R&R studies on measurement systems

• Manages the technical risk by developing a pFMEA with a strong control plan

• Use DOE (Design of Experiments) to perform process development in a controlled manner.

• Define the process capability Cpk of critical assembly stations

• Responsible for determining OQ parameters to start validation.

• Commissioning of equipment including all necessary change controls and training.

• Provide new opportunity (sales) support:

• Conducts and/or participates in customer meetings. Interacts with Sales and customers to determine requirements for new products/orders.

• Define processes for new device assembly business.

• Analyzes customer requests to determine equipment, tooling, or delivery systems needed.

• Support new proposal development by preparing equipment/engineering estimates for potential projects.

• Researches new trends and technologies in assembly automation and drug packaging; evaluates and tests new equipment and processes.

• Provide technical leadership/coaching to the engineering team.

• Be able to provide back-up for other NPI engineering value streams.

• 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. Working with teams on multiple shifts as needed.

• Leads CAPA investigations and actions, applying Lean Sigma concepts and DMAIC or similar problem solving methods. Initiate investigation activity and troubleshoot problems in packaging; discovers causes of non-conformance, i.e., slow throughput, poor quality and/or unsafe design.

EDUCATION OR EQUIVALENT:

• Bachelor of Science in Engineering and/or 5+ years of industry experienced required

• 5+ years relevant experience in equipment purchasing and validation, process improvement, and project management

• Six Sigma Green Belt or Black Belt certification preferred.

• Drug-device combination product assembly and/or pharmaceutical background preferred.

KNOWLEDGE SKILLS REQUIREMENTS:

• Expertise with assembly, packaging, and serialization automation equipment, with GAMP5 methodology preferred.

• Strong expertise with applied statistics for manufacturing process capability and variation reduction.

• Highly effective communication skills (verbal and written form).

• Effective at leading project teams and interfacing with customers and operations personnel.

• Ability to prepare and execute 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.

• High level of knowledge and experience in cGMP is desirable.

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Equal Employment Opportunity (EEO) Statement:

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.

PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled