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The Process Engineer is responsible for identifying and mitigating manufacturing issues (i.e., Aseptic Filling, Capping/Lyo operations, etc.) for existing business, through strong engineering and process improvement methods. The Manufacturing Process Engineer will play a critical role in creating/maintaining/improving manufacturing processes and procedures. They will also lead/assist in the commissioning, qualification, and validation of process equipment. All activities are focused on technical and operational support for the production, maintenance, and support staff 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, cross functional partnerships, tracking and analysis metrics, strong understanding, and utilization of good engineering practices, project management, and the use of Lean Six Sigma techniques. Additionally, the Process Engineer may be called upon to assess and provide recommendations for determining staffing, equipment needed, equipment purchase, equipment installation, component layout, and line layout.

Essential Duties and Responsibilities:

• Support technical activities related to new and existing products, process optimization, process & equipment troubleshooting, and process validation. The technical support includes Advanced Filling Isolator technology line(s) and appropriate equipment that helps function or is part of the overall Filling Isolator.
• Provide data gathering and analysis as needed to support technical projects and minimize waste and variability in the manufacturing process.
• Maximize the success rate for manufacturing operations by instituting programs to minimize human error, mechanical failure, filling isolator contaminations, procedural error(s) and improve yield/efficiency
• Write standard operational procedures (SOPs), standard test procedures, Engineering batch records, and other related GMP documents. Assist in the training of appropriate personnel.
• Responsible for troubleshooting process manufacturing equipment, supporting corrective action initiatives, and collaborating in ensuring utilities and manufacturing equipment meet operating specifications and remain compliant as required per SOPs and regulatory regulations
• Maintain a safety-first approach to manufacturing process development and manufacturing
• Approves validation protocols or other relevant documents as needed
• Commissioning of equipment, including all necessary change controls and training, including leading FAT & SAT activities. Evaluate and test new equipment and processes. This may include coordination of outside design, integration, and equipment manufacturing services.
• Research new trends and technologies in advanced aseptic filling/manufacturing. Evaluate and test new equipment and processes. This may include coordination of outside design, integration, and equipment manufacturing services.
• Collaborates with appropriate personnel on the development of new manufacturing equipment performance requirements
• Leads Manufacturing investigations and CAPA initiatives as needed.
• Writes and executes engineering protocols as needed.
• This position may require overtime and/or weekend work.
• Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, and guidelines
• Performs other duties as assigned by Manager/Supervisor.

Qualifications:

• Minimum of 3-6 years working in a Pharma cGMP environment; equivalent combination of education and experience will be considered.
• Exposure to parenteral processing equipment and operations, including formulation, filling, visual inspection, and packaging equipment preferred.
• Ability to manage teams to execute on-the-floor activities such as FAT, SAT, IQ/OQ, and Engineering batches. Experience in a data-driven approach to root cause analysis and prioritization of continuous improvement
• Intermediate/Strong Computer Skills: Ability to perform more complex computer tasks and knowledge of various computer programs to support the operation of the Aseptic Filling Isolator and its relevant equipment/parts
• Ability to explain complex technical issues to external customers/agencies.
• Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
• Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables.
• High Standard of Report Writing

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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.