Capital Projects Engineer Jobs

3 open positions found

Senior Engineer - Capital Projects & Process Design

BioPharma Consulting JAD GroupJuncos, PR, USonsite

The Senior Engineer provides independent technical leadership in process optimization, equipment characterization, and troubleshooting across operations, manufacturing, pilot plant, and capital project environments. This role applies advanced engineering principles to design and implement major system modifications, experiments, and process improvements. The engineer develops, analyzes, and presents technical interpretations for projects and operational issues of significant scope and complexity. RESPONSIBILITIES * Execute complex or novel engineering assignments requiring new or improved techniques. * Develop engineering policies and procedures impacting multiple organizational units. * Supervise, coordinate, and review the work of engineers, associates, and technicians. * Apply advanced engineering techniques and adapt specialized methods within area of expertise. * Support assignments outside primary discipline using broad engineering knowledge. * Serve as a peer‑recognized technical specialist, determining methodologies in at least one engineering area. * Apply mature engineering judgment in planning and executing projects. * Perform additional duties as assigned. * Develop innovative technical solutions to complex problems requiring creativity and strong analytical capability. * Collaborate with Research, Manufacturing, Process Development, Utilities, Facilities, Quality Assurance, and Validation to define requirements for large or highly complex system/facility modifications. * Partner with Project Managers to deliver engineering and design projects within scope, schedule, budget, and quality expectations. * Coordinate work with consultants, architects, and engineering firms to develop standard design documentation. * Develop departmental or project budgets involving multiple engineering disciplines. SKILLS * Strong knowledge of pharmaceutical/biotech processes and regulated documentation. * Familiarity with validation processes, including protocol development and execution. * Ability to apply engineering science to production systems and process optimization. * Proficiency with specialized laboratory equipment, process systems, and computer tools. * Expertise in at least three engineering technology areas. * Ability to troubleshoot routine to highly complex technical issues using scientific and engineering theory. * Strong analytical problem‑solving skills, including hypothesis development and data‑driven decision‑making. * Ability to determine when internal or external resources are required. * Ability to manage multiple projects simultaneously. * Experience in scheduling, facilitation, cross‑functional collaboration, and project follow‑up. * Contractor and vendor management experience. * Working knowledge of financial analysis tools and project cost development. * Ability to delegate and oversee project work of others. * Strong verbal communication and technical report writing. * Effective in technical presentations and cross‑functional collaboration. * Skilled in negotiation, conflict resolution, leadership, and team‑building. * Ability to work effectively with diverse communication and working styles. * Adaptability to change and ability to drive alignment across teams. Requirements EDUCATION \& EXPERIENCE REQUIREMENTS * Doctorate in Engineering OR * Master’s in Engineering + 2 years of engineering experience OR * Bachelor’s in Engineering + 4 years of engineering experience * Preferred academic backgrounds: Chemical, Mechanical, Industrial Engineering, or Biotechnology PREFERRED QUALIFICATIONS * Engineering experience in manufacturing operations within biotech, pharmaceutical, or other regulated environments. * Familiarity with automation systems, process equipment, and continuous improvement methodologies (Lean, Six Sigma, Kaizen, RCA). * Experience supporting CAPA, deviation resolution, and process optimization initiatives. * Strong cross‑functional collaboration with Operations, Quality, and Maintenance. * Knowledge of vision systems (inspection system analysis). * Experience in Packaging operations or equipment. Benefits * 6-month contract * Administrative Shift

3 months agovia universal intelligenceApply ›

Senior Engineer - Capital Projects

BioPharma Consulting JAD GroupJuncos, PR, USonsite

The Senior Engineer independently leads and directs process optimization, troubleshooting, and system improvement initiatives across operations, manufacturing, pilot plant, and capital project environments. This role applies advanced and diverse engineering principles to design and implement major system modifications, experiments, and capital projects. The Senior Engineer develops, analyzes, and presents technical interpretations for operational issues or engineering projects of significant scope and complexity, while providing leadership, technical expertise, and cross‑functional coordination. FUNCTIONS * Complete complex or novel engineering assignments requiring development of new or improved techniques and procedures. * Develop engineering policies and procedures impacting multiple organizational units. * Supervise, coordinate, and review the work of engineers, associates, and technicians on both ongoing and project‑specific bases. * Apply advanced engineering techniques and adapt specialized methods within area of expertise. * Apply engineering principles outside primary discipline to support a broad range of assignments. * Serve as a peer‑recognized technical specialist with responsibility for determining methodologies in at least one engineering area. * Utilize mature engineering judgment in planning and conducting projects. * Perform additional duties as assigned. * Develop innovative technical solutions to complex problems requiring creativity and strong analytical capability. * Collaborate with Research, Manufacturing, Process Development, Utilities, Facilities, Quality Assurance, and Validation to define requirements for large or highly complex system/facility modifications. * Work with Project Managers to deliver engineering and design projects within scope, schedule, budget, and quality expectations. * Coordinate work with consultants, architects, and engineering firms to develop standard design documentation. * Develop departmental or project budgets involving multiple engineering disciplines. SKILLS * Working knowledge of pharmaceutical/biotech processes. * Familiarity with validation processes and documentation in highly regulated environments. * Ability to operate specialized laboratory equipment and computer systems. * Ability to interpret and apply GLPs, GMPs, and engineering science to production. * In‑depth knowledge of validation requirements for new equipment installations. * Expertise in at least three engineering technology areas. * Ability to provide solutions to a wide range of technical problems of moderate to large complexity. * Strong analytical problem‑solving skills requiring scientific and engineering theory, calculations, and creative hypothesis development. * Ability to determine when internal or external resources are required to resolve issues. * Advanced data interpretation and technical decision‑making. * Ability to manage multiple projects simultaneously. * Experience in schedule development, facilitation, and project follow‑up. * Working knowledge of financial analysis tools and project cost development. * Ability to delegate and manage project work of others. * Experience managing contractors and vendors. * Strong verbal communication and technical report writing. * Effective in technical presentations and cross‑functional collaboration. * Skilled in negotiation, persuasion, conflict resolution, and team‑building. * Ability to work effectively with diverse communication and working styles. * Ability to manage change and drive alignment across teams. Requirements EDUCATION \& EXPERIENCE REQUIREMENTS * Doctorate OR * Master’s + 2 years of engineering experience OR * Bachelor’s in Engineering + 4 years of engineering experience Preferred: * Bachelor’s in Engineering + 4 years of engineering experience. PREFERRED QUALIFICATIONS * Experience in Commissioning \& Qualification (C\&Q) processes. * Experience with validation and packaging equipment. * Strong background in troubleshooting equipment and process systems in regulated environments. * Excellent communication and presentation skills in English and Spanish. * Strong organizational skills and ability to lead cross‑functional initiatives. Benefits * Administrative Shift * 1-year contract with possible extension

3 months agovia universal intelligenceApply ›

Capital Projects Engineer

ImClone SystemsBranchburg, NJ, UShybrid

Position Summary: This position is responsible for project delivery of capital or expense projects for the existing Celltrion Branchburg, LLC Facilities. Duties of this position include overseeing engineering projects and upgrades to the existing facilities, systems, and equipment. Junior levels within this role may also support senior Project Managers. Projects can involve direct and no impact equipment and systems or GMP and non-GMP facilities in the following areas: architectural renovation and construction; mechanical systems such as utilities and HVAC; process equipment; automation systems such as building management or monitoring systems; electrical systems; laboratory equipment; IT/IDS equipment; and life safety systems among others. Responsibilities of this position include assembling and leading a team through all aspects of a project lifecycle including initiation and planning; design; construction and installation; commissioning and qualification (known as verification); mechanical and technical completion; and turnover to end user. This also includes aspects that span project delivery including HSE management, project schedule, project change management, and project financials (estimation, capital requests, forecasts, capitalization, cost controls, etc.). This role owns or is otherwise responsible for the following: initial project scoping and cost estimation, safety planning, project schedule, resource identification (including contracted resources), contractor management, capital requests and capitalization, and project cost/schedule controls. Depending on project size or available Celltrion Branchburg resources, the PM may work with Procurement to contract various roles (i.e. design, automation programming, construction management, verification, etc.). In limited cases, the PM may also act as SME for systems where no SME has been identified. This role also drives on-schedule and on-budget execution of deliverables that they do not directly own such as user requirements development, design reviews, safety reviews, change controls (Q, HS, and/or E), operational readiness, etc. Key Objectives/Deliverables: Manage for Results /Strategic Planning: Ensure safety is built into the project from design through completion. Involve HSE representatives to provide user requirements and other input on various health, safety, and environmental aspects of project design, installation, and ongoing operation of systems and equipment. Work with project requestor, SME, and other stakeholders to determine project intent and scope including development of user requirements. Request for Proposal (RFP) or Request for Quotation (RFQ) development – prepare design or construction/installation RFP/RFQ based on defined scope of work following financial responsibility requirements. Develop capital requests for partial or full funding to deliver all aspects of project deliveries. Capital requests will be supported by quotes for materials or services provided. Complete capitalization at end of project upon invoice completion and placing the system in service. Develop and own project schedule through all phases of project delivery through system release. Support operational readiness activities, as needed. Manage the design process to ensure all project team members participate to define the requirements for a given project. Confirm a change control is approved for projects with quality and/or HSE compliance aspects prior to starting construction/ installation. For projects without quality compliance aspects, confirm other change management processes are being followed (i.e. automation changes, IT changes, etc.). Own changes, as required, or provide input or documentation, as needed, in support of change owners, Manage team of contractors to deliver scope of work as defined in design and/or specification documentation. Monitor progress versus schedule. Responsibilities also include developing and delivering logistics and communications plans, as necessary. Coordinate shutdowns activities with system or area owners. Own project controls processes for schedule and cost. Work with SME and commissioning and qualification personnel to successfully execute and document startup through system release requirements. Monitor progress versus schedule. For smaller projects, the PM may self-perform verification activities. Leadership of multiple engineering projects simultaneously with respect to buildings and grounds, equipment and systems for existing manufacturing, processing, laboratory, office and associated support facilities. Projects will range in size from approximately $10K to $5M. The position may also provide support for larger corporate engineering projects with values above $5M. Consultation and collaboration with SME in plant/process/automation to ensure technical requirements are met, project requirements are understood, and delivery timelines are established. Preparation of capital project approval documentation. Coordination of capital project tracking with Finance Department. Preparation of construction, equipment, and service bid packages. Coordination of bids and bid tabulation with the Procurement department. Perform construction management to ensure that projects are completed safely, on schedule and within established budgetary goals. For larger projects employing a construction management or general contractor, provide oversight to ensure work is occurring safely, on schedule, and in compliance with all applicable HSE and quality standards and programs. Acts a Subject Matter Expert on preparation of capital project approval documentation and process. Manage Relationships with Key Stakeholders and Customers: Project Manager will interact with SME, system user/owner, HSE, QA, QC, Facilities/Utilities, Validation, IT/IDS, design consultants and construction contractors. Basic Requirements: B.S. Engineering, Chemical, Mechanical, Electrical or other related engineering discipline required. Minimum three to five years of experience in project management and three to five years of experience managing projects in pharmaceutical/biotechnology industry. Experience working in a GMP environment preferred. Experience working with contracting firms and managing contractors. Experience with capital project execution. Strong written and verbal communication skills. Experience utilizing Microsoft Project or other project scheduling software. Experience and working knowledge of construction site safety practices and procedures and with construction of new building facilities and/or retrofitting of systems. Ability to work as a team leader to execute multi-disciplined projects. Strong organizational skills. Additional Preferences: Six Sigma experience a plus. Working knowledge of SAP is a plus. * CAPM or PMP certification is a plus. This is an exempt, salaried role with an anticipated compensation range of $87,000 – $172,000. Celltrion Branchburg, LLC offers a comprehensive benefits package that includes paid time off (holidays, vacation, and additional leave), medical, dental, and vision insurance, life insurance, a company-matched retirement savings plan, wellness programs, and short- and long-term disability coverage. The position does not require travel; it may require on-call availability and could involve shift work. Hybrid work flexibility is available based on business needs; relocation assistance is not provided. Celltrion is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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Companies hiring for Capital Projects Engineer

BioPharma Consulting JAD Group (2)ImClone Systems (1)

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