PCI Pharma Services

Operator

• Responsible, in conjunction with the Packaging Manager and Line Leaders, for shift output, quality, and yield in compliance with current GMP requirements
• Provide on-the-ground leadership to Line Leaders and Production Operators
• Ensure adherence to GMP practices and products conforming to customer specifications
• Complete and report production reports in Daily Operations Meetings
• Assess and modify the production plan with the Packaging Manager
• Prioritize and designate resources across production lines
• Prioritize kitting requirements with the Warehouse team
• Prioritize engineering requirements with the Engineering team
• Monitor batch changeovers, including line clearance, booking-in of batch components, and line start-up
• Monitor production line outputs, escalate under-performance, and ensure timely corrective actions
• Maintain customer product quality to expected standards
• Manage quality events with relevant Line Leaders
• Support and train Line Leaders
• Manage new and existing operator training with Line Leaders
• Monitor employee time and attendance compliance and escalate as required
• Complete quarterly Quantum conversations with designated Line Leaders and Operators
• Work positively with Production Operators, Team Leaders, Engineers, and the Packaging Manager
• Ensure safe work practices and report defects to the Packaging Manager and Safety Officer
• Deputize for the Packaging Manager / 2nd Team Leader for short-term holiday or illness cover
• Carry out additional tasks aligned with company goals
• Assist with technical aspects and projects as required by the Packaging Manager

Production Operator – Level 4

Full-stack Engineer

• Act as subject matter expert in isolated or RABS sterile fill finishing and lyophilization equipment and operations
• Manage Front End Engineering Design efforts, including project scopes, cost estimates, schedules, project charters, business requirements, and economic evaluations
• Manage external engineering partners and internal cross-functional teams
• Develop and implement segment-level engineering standards, baseline requirements, governance, standard work, and process documentation
• Investigate and recommend alternatives for design, procurement, and installation of equipment and systems
• Establish project teams and governance structures
• Lead manufacturing asset assessments and site master planning across the segment
• Conduct troubleshooting and technical analyses on operational equipment and processes
• Organize project governance communications and meetings
• Coordinate participation of Global Quality Tech Operations and Site Operations personnel in projects and continuous improvement efforts
• Drive Lean Manufacturing and Continuous Improvement culture and develop performance metrics
• Lead major capital projects, including technical support through gate processes, pre-construction activities, production coordination, contractor coordination, URS, risk assessments, and safety assessments
• Develop system requirements and equipment/building specifications; review external designs; oversee fabrication and lead Factory/Site Acceptance Testing
• Provide engineering mentoring to site engineering teams
• Support safety, stakeholder relationships, vendors, and continuous improvement initiatives

Principal Engineer, Global Technical Operations – Engineering & Innovation

Business Development Rep

• Support Business Development Executives in the daily management of accounts
• Prepare for and manage Quarterly Business Review Meetings
• Take and provide comprehensive meeting notes during client meetings
• Directly manage smaller client accounts
• Support the Lead Generation Manager in identifying global drug development targets
• Research drug development pipelines and identify appropriate contacts
• Coordinate cold calls, mailers, and geography-specific marketing lead campaigns
• Seek out, find, and develop new clinical business leads
• Research drug development companies and update information in Salesforce.com
• Make outbound calls to CROs, medical device, animal health, and cell & gene therapy organizations
• Attend client meetings and generate meeting minutes within two days
• Follow up on client and Global BD team information requests
• Respond to inquiries via email, website, phone, and trade shows
• Attend trade shows in a supportive capacity when required
• Manage PCI site visits, rooms, attendees, slide decks, and presentation materials
• Attend PCI site meetings on behalf of the Business Development Executive when appropriate
• Support and manage submission of CDAs or MSAs to PCI and client legal teams

Associate Clinical Business Development Executive

Executive Assistant

• Provide high-impact administrative and operational support to the Chief Financial Officer and LIFT organization, encompassing Legal, Finance, and IT
• Prepare professional-grade presentations and documents for senior leadership
• Manage complex, high-volume calendars across multiple time zones
• Coordinate domestic and international travel arrangements through Concur
• Prepare, submit, and track expense reports
• Draft, proofread, and edit confidential correspondence, reports, and executive materials
• Schedule conference rooms and manage logistics for executive meetings, board-related sessions, and customer visits
• Coordinate catering and on-site meeting support
• Provide on-site support at meeting locations for multi-day trips as needed
• Oversee document flow for executive signatures or review
• Order, maintain, and organize office and administrative supplies
• Support special projects and ad hoc initiatives for the CFO and LIFT leaders
• Ensure adherence to company policies, procedures, and applicable PCI, cGMP, and GCP guidelines
• Represent the Offices of the CFO, CIO, and General Counsel with professionalism and credibility
• Perform other duties as assigned

Executive Assistant – CFO

Analyst

• Perform validation activities to assure compliance with government and customer requirements
• Prepare validation protocols, validation statements, and master validation plans for new customer, product, and system launches
• Maintain existing validated processes and programs at multiple sites
• Organize and coordinate internal and customer approvals
• Ensure validation package documentation completion, accuracy, and closure
• Prepare change control and validation history reports for customer audits
• Attend conference calls and customer meetings and communicate project goals and progress to the Validation Supervisor/Manager
• Investigate validation deviations, document formal reports, and assure corrective action resolution
• Serve as customer contact for quality validation activities and manage customer expectations
• Review and interpret customer standards, procedures, and specifications for process and cleaning validation protocols
• Review production jacket and issuance for compliance with internal requirements
• Perform other duties as assigned

Validation Analyst 2

QA Engineer

• Apply and maintain quality standards for PCI Pharma Services and its products
• Maintain and perform quality management systems
• Work with production and customer service to ensure customer specifications and internal and regulatory GMP standards are met
• Apply company SOPs related to production, quality, and pharmaceutical packaging
• Review and approve inspection and production documentation
• Guide, coach, and direct production staff on quality issues
• Compile and maintain QA documentation and data
• Evaluate quality-control methods and recommend improvements
• Prepare deviation and incident reports
• Investigate customer complaints and report results to clients
• Review IORFs and determine supporting documentation requirements
• Complete annual product assessments as required by clients
• Monitor and adhere to GMP and occupational health and safety practices
• Conduct quality-management-system and annual GMP refresher training
• Conduct environmental monitoring in production areas
• Investigate temperature and humidity excursions and perform weekly report assessments
• Assist with external audits and responses to audit observations
• Perform quality-control inspections, line clearances, and line audits
• Approve material requisition forms for packaging, destruction, QA samples, rejects, and product adjustments
• Assess new products and determine whether APIs can be packaged at the site
• Lead and assess deviation, complaint, self-inspection, and CAPA procedures
• Initiate and manage CAPAs using root-cause analysis, containment, and permanent solutions
• Communicate corrective-action status, results, and impacts to stakeholders
• Ensure products and processes conform to SOPs and documented procedures
• Develop, monitor, and publish quality metrics
• Assess procedures for compliance, identify gaps, and recommend improvements
• Manage retained-sample storage
• Revise GMP documentation through the change-control system
• Develop test standards and procedures
• Perform delegated Senior QA Associate responsibilities and back up the Senior QA Associate and Quality Director
• Report to the Quality Director

QA Associate

• Grow profitable sales with existing customers and develop business with prospective new customers for the Midwest territory
• Meet sales goals set by management
• Focus on injectable and oral solid dose services, with packaging, labeling, and manufacturing within a CDMO environment
• Identify and contact prospective clients through email and telephone calls
• Communicate with team members about potential trends and market movement
• Update databases with business opportunities, client data, and communications
• Maintain and expand relationships with existing clients and internal teams
• Sell additional upstream and downstream services and execute pricing guidance
• Collaborate with the global proposals team on sales opportunities
• Negotiate final pricing and terms within stated parameters
• Attend and participate in sales meetings, conventions, and tradeshows
• Partner with BD colleagues in other segments to drive cross-selling opportunities
• Work with Quality and Operations to develop and improve industry knowledge
• Share industry knowledge with the BD team during monthly meetings
• Work with the VP of BD and Business Proposal Team to improve proposal templates and processes
• Perform other duties as assigned by the Manager/Supervisor