Process Engineer II

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 Process Engineer II role is focused on floor operations and eliminating waste to ensure a high-quality product is produced in a safe manner. The main functions of a Process Engineer are focused around five key activities of the plant for 1-2 value streams:

Primary 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

Secondary Responsibilities

• Specify, purchase, and commission new equipment and manage capital finances.
• Provide technical support for new business (Sales/Business Development Support).

All activities are focused around technical and operational support to the production, maintenance, and support staffs in the areas of process improvement, equipment modification and optimization, safety and quality improvement, and increasing throughput. This is achieved through individual effort and facilitation of teams, tracking and analysis metrics, strong understanding and utilization of good engineering practices, project management, and the use of Lean Six Sigma techniques. Responsibilities include determining staffing, equipment needed, equipment purchase, equipment installation, component layout and line layout.

Essential Duties and Responsibilities:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

• 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
• Management of the Equipment Acquisition and Installation Process Including:
  • Specifies equipment needed, prepares RFQs (Requests for Quote), and obtains quotes from vendors.
  • Writes CER's (Capital Equipment Requests) for new equipment, including researching the justification. Responsible for managing project budget and timeline.
  • Negotiates & orders equipment when approved.
  • Develop design criteria and equipment specifications, including safety, regulatory and necessary performance criteria.
  • Writes protocols for URS' (User Requirement Specifications), FAT's (Factory Acceptance Tests), & SAT's (Site Acceptance Tests).
  • Responsible for determining OQ parameters to start validation.
  • Approves validation protocols and MPI's.
  • Leads SAT/FAT for all assigned projects.
  • Commissioning of equipment including all necessary change controls and training.
• 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.

Supervisory Responsibilities:

No supervisory responsibilities.

Qualifications:

The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education or Equivalent:

• Bachelor of Science in Engineering or equivalent required
• 3-7 years relevant engineering experience.
• Lean Six Sigma Background preferred.
• Pharmaceutical and/or food packaging background preferred.

Knowledge and Skill Requirement:

• Familiarity with general industrial production equipment.
• Familiarity with pharmaceutical packaging equipment such as Blister, Pouch, Bottle, Tablet Feeding, Carton and Carding machinery is highly desirable.
• 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.
• Knowledge and experience in cGMP are desirable.
• Knowledge of Lean and / or Six Sigma is a plus.
• 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.

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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.

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.