Process Engineer III (Engineering)

Immediate need for a talented Process Engineer III (Engineering). This is a 06+ Months Contract opportunity with long-term potential and is located in Swiftwater, PA (Onsite). Please review the job description below and contact me ASAP if you are interested.Job ID:26-10568Pay Range: $59 - $69/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location). Key Responsibilities:The Continuous Improvement Contractor will execute the following activities and responsibilities:Cross-Functional Collaboration and SupportServe as an individual contributor and active member of cross-functional teams providing support to Production Control Units (PCUs)Act as CAPA (Corrective and Preventive Action) and Change Control point of contact for the Formulation and Filling Improvement Program (FFIP), with emphasis on Formulation and Filling areasFacilitate cross-functional interfacing activities with key stakeholders in a positive and collaborative manner, including, but not limited to:Quality ControlManufacturing Science and Technology (MSAT)Sterility AssuranceEngineeringOperationsQuality AssuranceCAPA and Change Control ManagementComplete all required training to independently own CAPA action items, Change Control action items, and author related documentsEnsure timely closure of assigned CAPA and Change Control action itemsMaintain accountability for deliverables and adherence to established timelinesTechnical Support and Process ImprovementProvide technical support for:Component qualification activitiesOverall Equipment Effectiveness (OEE) improvement initiativesElectronic Batch Record (eBR) implementation and optimizationOpstrakker system utilizationGeneral factory improvement projectsFacilitate resolution of unresolved issues and deliverables by:Leading cross-functional meetingsPositively influencing functional managersRemoving obstacles and barriers to progressManaging projects and competing priorities effectivelyOperational Excellence and Metrics ManagementCreate and maintain a proactive operational environmentMonitor and communicate key performance metrics to team members and support functionsUtilize the \" QDCI\" Visual Management Systems to drive continuous improvement in key metricsWork within the Continuous Improvement framework to identify and implement improvement opportunitiesCompliance and Quality AssuranceEnsure strict compliance with all regulatory requirements and current Good Manufacturing Practices (cGMPs)Maintain adherence to good documentation practices to ensure delivery of safe, quality, and effective productsSupport regulatory inspections and audits as requiredKey Requirements and Technology Experience:Skills-Minimum 5 years of related experienceMinimum Education: Bachelor's DegreeTechnical Knowledge and ExpertiseManufacturing Operations: Deep understanding of cGMPs and pharmaceutical manufacturing activities, including:Formulation processesFilling operationsLyophilization (freeze-drying) processesContinuous Improvement Methodologies:Comprehensive knowledge of Lean Manufacturing concepts and principlesSix Sigma methodology and toolsChange Management: Demonstrated experience in Change Management processes and executionProtocol and Report Development: Proven experience in authoring protocols and technical reportsSystems and Tools ProficiencyMicrosoft Office Suite: Proficient in Excel, Word, and PowerPointEnterprise Resource Planning (ERP): Knowledge of ERP systems (iShift preferred)Quality Management Systems: Experience with Quality Management Systems (Qualipso)Electronic Systems: Familiarity with eBR and Opstrakker systemsCore Competencies and Soft SkillsCommunication: Excellent interpersonal and communication skills with ability to engage effectively across all organizational levelsLeadership: Strong management by influence skills; ability to lead and actively participate on cross-functional teamsTechnical Writing: Excellent technical writing skills for generation of protocols, reports, and Change ControlsProject Management: Strong project management and organizational skillsTime Management: Demonstrated ability to prioritize tasks and manage time effectively in a fast-paced environmentFlexibility: Adaptability to change priorities and business needsProblem-Solving: Analytical mindset with ability to identify root causes and implement effective solutionsSchedule-Major required milestones to support the project and estimated hours:Activity Description Expected Duration Expected Duration (hrs.)Continuous Improvement Contractor Apr2026 – Oct2026 1000HM Notes: Fully onsite position, however, may offer 1 day off site, day of the week varies, at manager's discretionShort assignment, firm 6-month TBD• Bachelor’s degree, engineering life sciences, engineering open all levels5 years of experience, open to all levelsMust have : Biotech, Pharma experience • Willing to relocate at their own expense, prefer locates only Top skills: CAPA • Change Controls , Authoring of documents of protocolsPreferred: Vault or Calipso, or GMP Compliance document system or similarQuality background is a plus, manufacturing and or validationKnowledge of ERP systems (iShift preferred) , Root Cause Analysis, inspections.Our client is a leading Pharmaceutical Industry and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.By applying to our jobs you agree to receive calls, AI-generated calls, text messages, or emails from Pyramid Consulting, Inc. and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here.