Process Equipment Engineer

Facilities & Utilities Manager

Assistant R&D Manager

Senior Director of Operations

Role Description: <ul><li>The Process Equipment Engineer will be a key technical leader responsible for the design, specification, procurement, installation, qualification, and ongoing reliability of process equipment for a greenfield sterile injectable IV bag manufacturing facility.</li><li>This role will play a critical part in ensuring that all manufacturing equipment all sterile manufacturing equipment are compliant with cGMP requirements, supports aseptic processing standards, and are capable of delivering high-quality product performance from day one of commercial operations. </li><li>Equipment includes sterile isolators, compounding, automated inspection, and secondary packaging for the production of sterile IV bags.</li><li>Working cross-functionally during the startup phase, the incumbent will drive equipment readiness, validation support, and serve as a technical subject matter expert (SME) for process equipment throughout the facility lifecycle.</li></ul> Responsibilities: <ul><li>Lead the specification, selection, and procurement of sterile injectable manufacturing process equipment, including isolator filling lines, formulation vessels, mixing systems inspection equipment, secondary packaging equipment, and associated support systems.</li><li>Develop user requirement specifications (URS), functional specifications (FS), and detailed equipment design documentation in compliance with regulatory and operational standards.</li><li>Manage equipment vendors, design reviews, factory acceptance testing (FAT), site acceptance testing (SAT), and oversee equipment delivery, installation, and commissioning.</li><li>Promote and ensure adherence to safety protocols and safe work practices.</li><li>Perform risk assessments for engineering and maintenance activities.</li><li>Collaborate with Validation, Quality, and Operations teams to support equipment qualification (IQ/OQ/PQ) and ensure all systems meet regulatory expectations for sterile manufacturing.</li><li>Establish preventative maintenance programs, spare parts inventories, and equipment lifecycle management plans to ensure long-term equipment reliability and availability.</li><li>Provide technical expertise during troubleshooting, deviations, and investigations related to process equipment performance, ensuring rapid resolution of issues.</li><li>Partner with Manufacturing and Quality teams to optimize equipment performance, drive continuous improvement initiatives, and support ongoing process optimization.</li><li>Identify and implement process improvements to enhance operational safety, efficiency, and reliability.</li><li>Support development of SOPs, equipment manuals, and operator training programs to ensure safe and compliant operation of process equipment.</li><li>Ensure equipment designs fully comply with cGMP, FDA, OSHA, and all applicable regulatory and safety standards.</li><li>Contribute to capital project planning, budgeting, and project execution related to new equipment or facility expansions.</li><li>Ensure ongoing regulatory inspection readiness and serve as SME for process systems during audits and inspections.</li></ul> Requirements: <ul><li>Bachelor’s degree in mechanical engineering, Chemical Engineering, Industrial Engineering, or related field.</li><li>3+ years of experience in pharmaceutical process equipment engineering, with significant exposure to sterile injectable manufacturing strongly preferred.</li><li>Direct experience with design, procurement, and qualification of aseptic manufacturing equipment and cleanroom environments.</li><li>Solid understanding of cGMP regulations, FDA/EMA expectations, and engineering best practices for sterile operations.</li><li>Experience working in greenfield or major facility expansion projects highly desirable.</li></ul> Skills/Competencies: <ul><li>Strong technical knowledge of process equipment design, aseptic manufacturing, and utility systems.</li><li>Proven project management skills with ability to handle complex, cross-functional projects.</li><li>Excellent problem-solving abilities and root cause investigation experience.</li><li>Effective communication and vendor management skills.</li><li>Ability to work independently in a fast-paced, startup-like environment.</li><li>Strong teamwork, collaboration, and continuous improvement mindset.</li><li>High attention to detail with strong commitment to safety, compliance, and product quality.</li></ul>

Responsibilities: <ul><li>Lead KWS RM COE and own equipment criticality element as part of the facilities and utilities operation.</li><li>Lead Facilities &amp; Utilities team insourcing maintenance strategy with a strong technical development plan</li><li>Delivery highest level of facilities and utilities machine reliability with the optimum level of preventive, corrective &amp; condition-based base maintenance strategic formulation and implementation.</li><li>Lead and implement integrated facilities management for factory-wide facilities management/maintenance. This includes the hard and soft service of the facilities management.&nbsp;</li><li>Key member and element owner of Technical COE on FUS and drive all global FUS programs.</li><li>Key member of NRC COE to drive sustainability agenda through out the factory.</li><li>Develop good relationships with other regional factories and strive for cross-learning and implementation of best practices for plant performance and KWS.</li><li>Owns engineering facilities and utilities R&amp;M cost budgeting and end-to-end management and monitoring.&nbsp;</li><li>Conducts effective cost reduction initiatives in line with ZLA &amp; KIMMS projects.&nbsp;&nbsp;</li><li>Leads ongoing cross-functional teams to conduct analyses of plant savings opportunities, identify CAPEX investment opportunities, and make strategic investments to support growth and machine reliability.</li><li>Provide coaching, and guidance &amp; lead the team towards a high-performing team.</li><li>Leads the team as the expert point of contact for facilities and utilities for the whole plant and provides support accordingly.</li><li>Owns Technician Training and development systems in support of Technician Progression</li><li>Responsible for Site Daily Meeting Cadence with Tier 1-4 meetings and ensure they are healthy for results sustainability.</li><li>To guard standards and regulations on EHS, QFS, and other fundamentals by participating in and coaching during Leader Led Observations, Safety 7, Golden 6, and other EHS and QFS activities.&nbsp;</li><li>Always maintain a good level of documentation and evidence management to support all internal and external audits. (QFS, KWS, EHS, DOSH, FSSC, HACCP, HALAL, and Global programs on FUS)</li></ul> Requirements: <ul><li>Degree in Chemical/Mechanical/Electrical Engineering or related discipline with at least 10 years of working experience.</li><li>Sound practical knowledge of mechanical engineering (rotating equipment, fasteners, bearings, gearbox, valves, thermodynamics, material strength &amp; compatibility, etc.)</li><li>Sound technical knowledge of utilities &amp; facilities equipment working mechanism and working principle (compressed air, WWTP, HVAC, chiller, coiler, hoist, rapid door, building maintenance (roof, drain, floor, etc.), electrical power supply, water supply, gas supply, nitrogen gas supply, etc.)</li><li>Preferably having work experience in F&amp;B industries with experience in SAP system</li><li>Technical experience in the following systems:&nbsp;</li><li>Six Sigma DMAIC process and strong analytical knowledge to lead and resolve complex issues.</li><li>Strong knowledge and awareness of different types of leadership and hands-on experience.&nbsp;</li><li>Capable of formulating different types of strategies to increase reliability, effectiveness, and collaboration of facilities and utilities teams to drive results in a sustainable way</li><li>Numerical literacy of basic electrical engineering (motor power, electrical load, cable sizing) and process engineering (basic mathematics related to the physics of pressure, temperature, level, force, etc.)</li><li>Sound hands-on experience in facilities &amp; utilities maintenance strategy formulation and conducting insourcing maintenance.&nbsp;</li><li>Exposed and have hands-on experience with pillar approached performance management (KWS), CI tools, analysis tools, sound problem-solving skills, and coaching skills.</li><li>Six Sigma Green Belt project implementation experience &amp; CAPEX project management will be an added advantage</li></ul>

Purpose of the role: <ul><li>Create new and improve existing foods and processes by applying technical, food science and culinary skills in cereals through complex formulas, processing procedures and specifications for new products, product enhancements, and cost reductions to meet project needs in a constantly evolving business environment.</li><li>Capable of working at a fast and agile pace on multiple projects simultaneously, whilst interacting successfully with internal and external stakeholders.</li></ul> Responsibilities: <ul><li>Key contributor within the experienced R&amp;D team supporting all development and commercialization aspects (including Food &amp; Packaging) of new product introductions, as well as productivity and quality improvements of existing products.</li><li>Develop experimental formulas, processing procedures, and specifications for raw ingredients, subassemblies, and finished products for simple new product, product improvement, and cost optimization by applying technical, food science and culinary skills and by interpreting consumer and customer needs and assembling input from cross-functional teams. Effective collaboration and communication cross functionally.</li><li>Evaluate ingredients and processing techniques to identify and commercialize product improvement and cost optimization opportunities.</li><li>Prepare prototype products to the design brief and present to the business through leading effective food reviews.</li><li>Design, plan and execute experiments for bench top, pilot plant and plant trials, gather and analyze data, document and report results, and make recommendations.</li><li>Ensure successful start-ups of new products, product improvements, cost reductions, and ingredient, formula, specification, or process changes from product concept development, formulation design, prototype development, cost calculation, specifications, quality assessment, legislation compliance checks and claim assessments.</li><li>Document all work according to guidelines and provide timely project reports to ensure good communication of project status, progress, issues and timeline.</li><li>Support labeling, nutritional, regulatory, quality and food safety efforts.</li><li>Create Nutritional Label Information.</li><li>Actively research for opportunities, trends, consumer insights and competitor landscape.</li><li>Develop and maintain understanding of local/regional regulations &amp; legal requirements and their standards. Develop claims and products at EU level, ensure approval for each launch country with regional Regulatory Affairs &amp; Legal functions.</li></ul> Requirements: Knowledge: <ul><li>Bachelor’s degree in food science, Food Engineering, Chemistry or related fields desirable.</li></ul> Experience: <ul><li>1-3 + years of industrial experience in the food industry.</li></ul> Skills and Abilities: <ul><li>Knowledge and experience with ingredient functionality, product design and formulation, and commercialization</li><li>Solid knowledge and understanding of food chemistry, food processing, and food functionality.</li><li>Strong technical and project management skills with results orientation</li><li>Excellent written and verbal communication skills; able to effectively communicate to all levels within the organization.</li><li>Professional working proficiency in English (Reading, Writing and Speaking).</li><li>Ability to collaborate cross-functionally, building strong relationships across R&amp;D, Marketing, Finance, Procurement, Quality, Manufacturing, Planning and External Stakeholders.</li><li>Ability to effectively influence others and get results through working with a diverse team, and to continuously challenge assumptions to seek innovative solutions.</li><li>Demonstrated ability to prioritize and manage complexity.</li><li>Executional excellence, personal leadership, time management, organization, and problem solving competencies.</li><li>Ability to be flexible and adaptable to move with a changing environment.</li><li>Ability to define problems, collect data, establish facts, draw valid conclusions, and offer solutions.</li><li>Ability to thrive in a face-moving, dynamic, team environment that encompasses end-to-end development (concept and exploration through manufacturing scale up, start up and process optimization).</li><li>Passion for food and the environment</li><li>Ability to work flexibly when required. Interstate and overseas travel may be required</li></ul>

Responsibilities: <ul><li>Responsible for the day-to-day operations and longer term planning for manufacturing functions, including manufacturing, production control, engineering, inventory control, purchasing and shipping/receiving activities. Defines goals, improves technologies, and resolves problems.&nbsp;</li><li>Translates customer requirements into state-of-the-art manufacturing strategies and processes, resulting in cost effective processing and profitable manufacturing of company products. Develops operations-related plans, budgets, and policies and procedures. A key member of TE Energy team, directing Operations and responsible for the planning, controlling, manufacturing, production of goods, and service delivery. </li><li>Operations is also responsible for quality service delivery and supply chain management needed to ensure materials arrive to produce goods and ensure that orders are processed and shipped appropriately. </li><li>In addition to on time deliveries to global customers, the U.S. location is responsible for supplying critical function components to global customers for rapid end item configurations and delivery to customers.&nbsp;</li><li>Direct oversight to ensure that operations is running efficiently and effectively, and that demand is met.&nbsp;</li><li>Partner with the BU General Manager and other senior leaders in a matrixed organization in the development and formulation of long and short-range strategic planning, budgets (including capital investment), policies, programs, and objectives.&nbsp;</li><li>Drive innovation management through the business keeping abreast of market trends and creatively applying new technologies across the entire operations value chain.&nbsp;</li><li>Monitor and oversee Quality and Continuous Improvement (TEOA) initiatives to enable the BU to meet or exceed plan targets. This includes manufacturing, procurement, and business processes.&nbsp;</li><li>Define required strategies and define infrastructures and organizational structures to meet company, customer and market expectations proactively. </li><li>Develop, coordinate and drive the operations plans and establishes procedures for maintaining high standards of operations to ensure that products and processes conform to established customer and company standards.&nbsp;</li><li>Cascade strategic objectives for Operations functional leadership. Set and clarify requirements and expectations for direct and matrixed reports based on the strategic direction and needs of the business.&nbsp;</li><li>Work closely with Human Resources to lead the team with integrity and to establish and maintain a trusting, inclusive, and productive environment that promotes employee wellbeing, engagement &amp; quality of life.&nbsp;</li><li>Develop and deliver clear and concise communications both up, down, and sideways across the organization.&nbsp;</li><li>Organize Plant and supplier’s capacity and technical capabilities to meet planned production schedules.&nbsp;</li><li>Monitor and oversee operational activities with the objective of maximizing the use of organizational resources to meet and/or exceed established KPI’s (TEOA (Lean), Safety, Quality, Delivery, Inventory, and Cost.).&nbsp;</li><li>Drive organization structures and programs (footprint changes, migration/localization, new product launch, process and equipment requirements) to meet BU/regional goals.&nbsp;</li><li>Monitor and oversee the full value chain from procurement and production to shipment and beyond.&nbsp;</li><li>Work actively with supply chain leaders to ensure that supply is consistently synchronized to demand to maximize revenue and delivery performance.&nbsp;</li><li>Take a holistic view of global capacity and through the S&amp;OP process plan the necessary global capacity expansions or shifts to align regional supply to regional demand.&nbsp;</li><li>Work closely with Plant Controllers and Plant Managers to understand spending activities &amp; trends, how they match up to targets, and course correct. </li><li>Draw on relationships with department heads, external partners, and vendors to make decisions regarding operational activity and strategic goals&nbsp;</li></ul> Requirements: <ul><li>In this section, list the core requirements for this job.&nbsp;</li><li>Next to each, list the level of proficiency desired for this job. Proficiency level descriptions are in the appendix. Core Competencies (no greater than 10 Lominger Competencies – From Lominger Questionnaire) Proficiency Level&nbsp;</li><li>Action oriented&nbsp;</li><li>Being resilient&nbsp;</li><li>Ensures Accountability</li><li>Communicates effectively&nbsp;</li><li>Drives Engagement</li><li>Directs work</li><li>Drives results</li><li>Develops Talent</li><li>Plans and aligns 3/4</li><li>Situational adaptabilit</li><li>Values differences</li><li>Balance stakeholders&nbsp;</li><li>Building effective teams</li><li>Decision Quality Experience Ten or more years in a senior leadership role in a field related to our industry&nbsp;</li><li>Masterful organizational, communication, and leadership skills, backed by previous professional success&nbsp;</li><li>Superior knowledge of multiple operational functions and principles, including finance, customer service, production, and employee management&nbsp;</li><li>Proven ability to plan and manage operational processes for maximum efficiency and productivity&nbsp;</li><li>Ability to streamline or implement structures and roles that boost speed and efficiency while supporting rapidly shifting business demands</li><li>Strong working knowledge of industry regulations and legal guidelines&nbsp;</li><li>Excellent executive presence, ability to present to senior leadership&nbsp;</li><li>Experience in managing cross-functional teams and working in a matrix organization.&nbsp;</li><li>Experience with Lean Manufacturing and Six Sigma methodologies.</li><li>Familiarity with ERP systems and their role in manufacturing.&nbsp;</li><li>English speaking and other languages advantageous.&nbsp;</li><li>Experience in developing budgets and business plans&nbsp;</li><li>Superior negotiation skills for both internal and external purposes&nbsp;</li><li>Strong working knowledge of data analysis and performance metrics, using business management software (ex: SAP, ERP, CRM) Education</li><li>Bachelor’s degree in manufacturing engineering, Mechanical Engineering, Industrial Engineering, or a related field.</li></ul>

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Process Equipment Engineer

Facilities & Utilities Manager

Assistant R&D Manager

Senior Director of Operations

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4 formulation Jobs found

Process Equipment Engineer

Facilities & Utilities Manager

Assistant R&D Manager

Senior Director of Operations

WhiteCrow WhiteCrow is on a mission to connect companies with the best talent across the globe.

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