Automation Engineer

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

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

• Conceptualize manufacturing processes in support of new business opportunities (Sales/Business Development Support)
• Develop specifications (URS), manage assembly automation 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

Activities 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 INCLUDE THE FOLLOWING (OTHER DUTIES MAY BE ASSIGNED):

• 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 the new device assembly business.
  • Analyze 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; discover causes of non-conformance, i.e., slow throughput, poor quality, and/or unsafe design.

SUPERVISORY RESPONSIBILITIES:

No supervisory responsibilities.

EDUCATION OR EQUIVALENT:

• Bachelor of Science in Engineering and/or 10+ years of industry experience required
• 5+ years of 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.
• A high level of knowledge and experience in cGMP is desirable.

COMPUTER SKILLS:

• Fully competent in the use of computer software - Microsoft Windows, Microsoft Word, Microsoft Excel, and Microsoft PowerPoint.
• Ability to use Microsoft Project or similar project management software, Visio, Minitab or similar statistical software, AutoCAD or similar 3D CAD software.

PHYSICAL DEMANDS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Must be physically capable of performing the above duties with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.

WORK ENVIRONMENT:

Office and Production floor environment.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

Join us and be part of building the bridge between life changing therapies and patients. Let's talk future

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.

At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.