Senior Process Engineer

Senior Talent Acquisition Specialist | Client Services | Driving Talent Solutions @ACL DigitalIdeal Candidate: B.S. and 5+ YOE, manufacturing project implementation, new equipment, regulated industry experience. Prior Pharma experience would be nice to have.Job Summary:This role provides engineering support for projects and manufacturing activities, working in close collaboration with system owners, project teams, and cross-functional stakeholders. The Sr Engineer will leverage an engineering background to drive project implementation, continuous improvement initiatives, and system reliability. The role requires balancing technical problem-solving, project execution, and operational support, with a focus on compliance, safety, and business continuity.The Sr Engineer will:Partner with system owners, maintenance, project management, and manufacturing to ensure reliable operation and execution of equipment and systems.Lead or support engineering-based improvements and capital projects, including requirements definition, design, construction, startup, and validation.Drive continuous improvement by applying Lean principles, Six Sigma, and other methodologies to reduce costs, improve quality/safety, and increase operational efficiency.Support commissioning, qualification, and performance verification activities for equipment and systems.Provide oversight into contractors and vendor deliverables and ensure adherence to standards.Act as liaison between Engineering and Manufacturing during project planning, execution, and closeout.Provide technical root cause analysis, troubleshooting, and problem-solving support to minimize downtime.Support new product/technology introductions through engineering assessments and equipment modifications.Ensure compliance with environmental health, safety, and regulatory requirements during all engineering activities.Deliver coaching and guidance to project teams on commissioning, qualification, and process risk-based approaches.This position requires onsite support with occasional flexibility to cover after-hours engineering needs in support of 24/7 operations.Demonstrated SkillsTechnical report writing, documentation, and presentationsStrong verbal and written communicationOrganizational and change management skillsAnalytical problem-solving and scientific/engineering reasoningExperience with systems such as Maximo, TrackWise, E-Builder, PCS, BMS, and QEMSAbility to manage multiple projects and troubleshooting activities simultaneouslyBasic project management and cost estimation skillsConflict resolution and cross-functional collaborationContractor and vendor managementDevelopment of SOPs and training deliveryCustomer service in a technical environmentPreferred Qualifications / Skills / ExperienceBachelor’s degree in chemical, Mechanical, Electrical, or related Engineering field6+ years of relevant engineering experience, with at least 5+ years in a biopharmaceutical or regulated manufacturing environmentExperience working in compliance-driven settings (e.g., cGMP, OSHA, EPA)Direct knowledge of design, operation, and troubleshooting of GMP production equipment (e.g., chemical reactors, chillers, tablet press, dosage, clean utilities, etc.)Demonstrated ability to apply engineering principles to system modifications, process improvements, and capital project executionKnowledge of safety requirements and quality systems in a biopharmaceutical environment (change control, deviations, CAPA, validation)Proven ability to lead and collaborate within cross-functional project teamsStrong leadership, technical writing, and presentation skillsIndependent, self-motivated, organized, and able to adapt to dynamic project environmentsBasic QualificationsDoctorate degree OR Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience OR Associates degree and 8 years of experience OR High school diploma / GED and 10 years of experienceTop 3 Must Have Skill Sets:Projects, Continuous Improvement and Analytical problem solving.Day to Day Responsibilities:Working in close collaboration with system owners, project teams, and cross-functional stakeholdersSeniority levelMid-Senior levelEmployment typeContractJob functionManufacturing, Distribution, and EngineeringIndustries: Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment ManufacturingWe’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr

Created: 2025-09-21