Principal R&D Innovation Engineer

Quality Engineer

Microbiology Technician

Facility Mechanic

Technical Support Manager

Responsibilities: <ul><li>In conjunction with sales and product management, engage and partner with customer innovators and influencers to understand their challenges, their needs, the value they provide, and their future requirements.</li><li>Analyze emerging technologies to identify potential technology integration and product opportunities.</li><li>Contribute to the creation and maintenance of technology roadmaps.</li><li>Collaborate with cross-functional teams to develop and refine new product concepts.</li><li>Define, coordinate, and execute technology development projects in line with the technology roadmaps.</li><li>Stay current with industry developments, competitive landscape, end users’ system architecture and industry standards.</li><li>Drives the spirit of innovation into the organization to design and launch differentiated products.</li></ul> Requirements:&nbsp; <ul><li>Bachelors degree in an Engineering discipline (Master’s degree, preferred).</li><li>12+ years’ relevant experience including new product development, technology development &amp; demonstration, and customer-facing or customer collaboration roles.</li><li>Ideal candidate will have a deep knowledge of the utility, industrial and renewable industries.</li><li>Demonstrated ability to think creatively and solve complex problems.</li><li>Possesses high degree of initiative, technical competence, hands-on experience and engineering process knowledge.</li><li>Excellent communication and presentation skills.</li><li>A professional level of business acumen.</li></ul>

Responsibilities: <ul><li>Act as technical expert and provide QA support during facility, utility, manufacturing equipment, and laboratory instrument qualification by reviewing qualification and validation protocols for clarity, compliance, and alignment with regulatory and internal quality expectations. Collaborate with cross-functional teams to ensure timely and compliant execution of commissioning, qualification, and validation activities</li><li>Review and approve qualification protocols and final reports (equipment, utilities, facilities, processes) to ensure alignment with quality and regulatory standards.</li><li>Support execution of qualification protocols by providing on-site quality presence during testing and ensuring deviations are properly documented and escalated</li><li>Provide QA support during technical transfer and process validation of new products.</li><li>Provide support to operation during Change Control and Deviation process. Drive timely and compliant resolution of deviations, non-conformances, and CAPAs arising during operations and qualification activities. </li><li>Support the development and maintenance of site-specific quality procedures (SOPs, work instructions, forms) governing manufacturing, warehousing, engineering, maintenance, and validation operations.</li><li>Maintain awareness of site policies, cGMP regulations, and evolving regulatory expectations applicable to sterile injectable operations.</li><li>Provide QA support during regulatory inspection. Participate in internal walkthroughs and audit. &nbsp;</li><li>Prepare quality and compliance metrics to support continuous improvements</li></ul> Requirements: Qualifications/Experience <ul><li>Bachelor’s degree in a scientific, engineering, or technical discipline (e.g., Biology, Chemistry, Pharmacy, Engineering)</li><li>Minimum of 7-10 years of experience in quality assurance, manufacturing, or validation in a cGMP-regulated pharmaceutical or biotech manufacturing environment</li><li>Working knowledge of FDA, EU, and ICH guidelines related to sterile manufacturing, validation, and data integrity</li><li>Experience supporting commissioning and qualification activities </li><li>Ability to work collaboratively with operations, engineering, and validation stakeholders</li></ul> Skills/Competencies <ul><li>Strong attention to detail and commitment to compliance</li><li>Solid written and verbal communication skills</li><li>Ability to work collaboratively across departments in a fast-paced environment</li><li>&nbsp;Strong knowledge of validation principles and qualification documentation </li><li>Proficient in using quality systems and document management tools</li><li>Flexible and adaptable to changing priorities and evolving project timelines</li><li>Commitment to data integrity, continuous improvement, and patient safety</li></ul>

Responsibilities: <ul><li>Perform routine environmental monitoring (viable and non-viable) in classified cleanroom areas (Grade A/B/C/D), including surface and personnel monitoring. Manufacturing is performed inside isolators with surrounding grade C environment.</li><li>Collect and test samples from water systems (e.g., purified water, WFI), compressed gases, and other utilities per GMP and site procedures.</li><li>Support aseptic process simulations (media fills), including preparation, execution, and recovery/interpretation of microbiological data.</li><li>Perform microbiological tests such as bioburden, endotoxin (LAL), and sterility testing for raw materials, in-process samples, and finished products.</li><li>Prepare microbiological media, perform growth promotion testing, and maintain inventory of reagents and supplies.</li><li>Maintain laboratory notebooks, logs, and electronic systems in a compliant and organized manner, ensuring adherence to data integrity standards.</li><li>Support qualification and validation activities including cleanroom and utility qualifications, method validations, and EM qualification mapping.</li><li>Assist in investigations related to microbial excursions or deviations and contribute to the development and implementation of CAPAs.</li><li>Support microbiology lab startup activities including equipment qualification, SOP development, and execution of technical transfer protocols.</li><li>Follow all safety, quality, and regulatory policies, and maintain compliance with cGMP, USP, EU Annex 1, and other applicable guidelines.</li></ul> Requirements: Qualifications/Experience: <ul><li>Associate’s or bachelor’s degree in microbiology, Biology, Life Sciences, or a related field.</li><li>1–3 years of microbiology laboratory experience in a GMP-regulated pharmaceutical or biotechnology manufacturing environment.</li><li>Experience working in sterile environments or supporting aseptic processes preferred.</li><li>Familiarity with environmental monitoring equipment (e.g., particle counters, air samplers), microbiological techniques, and lab instrumentation.</li><li>Knowledge of cGMPs, data integrity principles, and microbiological standards (USP &lt;61&gt;, &lt;62&gt;, &lt;71&gt;, &lt;85&gt;, &lt;1116&gt;).</li></ul> Skills/Competencies: <ul><li>Strong attention to detail and commitment to data accuracy and integrity.</li><li>Ability to work independently while collaborating effectively within a team</li><li>Good time management and organizational skills to support multiple tasks and priorities.</li><li>Proficient in the use of Microsoft Office and basic laboratory software systems.</li><li>Willingness to work flexible shifts or weekends to support aseptic operations and testing schedules, as needed.</li><li>A proactive and patient-focused mindset with a strong sense of ownership and compliance.</li></ul>

Responsibilities: <ul><li>Perform preventive and corrective maintenance, troubleshooting, and repairs on facility infrastructure and critical utilities, including HVAC systems for cleanroom environment, compressed air and vacuum systems, clean utilities (WFI, purified water, clean steam), boilers, chillers, temperature control units, and effluent water treatment equipment.</li><li>Support equipment setup, calibration, qualification, and creation of maintenance plans of facility utilities and equipment.</li><li>Conduct round and inspection to monitor system performance and proactively address issues.</li><li>Ensure proper gowning, cleanliness, and contamination control practices when working in classified cleanroom environments.</li><li>Document all maintenance activities accurately in maintenance logs, work orders, and computerized maintenance management systems (CMMS).</li><li>Collaborate with Engineering, Manufacturing, and Quality to support equipment investigations, deviations, and continuous improvement initiatives.</li><li>Follow all safety procedures, including lockout/tagout, confined space, and PPE use; actively contribute to a culture of workplace safety and compliance.</li><li>Maintain spare parts inventory, tools, and maintenance supplies in an organized and audit-ready condition.</li><li>Participate in training and cross-functional activities to support plant startup and readiness for regulatory inspections.</li><li>Provide technical support of production activities during absence of production support team members or when bandwidth is insufficient.</li></ul> Requirements:﻿ <ul><li>High school diploma or technical certificate required, Associate’s degree in a mechanical or technical field preferred.</li><li>3+ years of experience as a mechanic or technician maintaining utilities or facilities infrastructure in a pharmaceutical, biotech, or regulated manufacturing environment.</li><li>Experience with pharmaceutical manufacturing equipment and cleanroom protocols is highly desirable.</li><li>Strong troubleshooting skills for mechanical, electrical, and control system issues.</li><li>Familiarity with building management systems (BMS) and alarm monitoring systems.</li><li>Solid electrical and controls experience with automated systems, inspection machines, robotics, and camera systems highly preferred.</li><li>Understanding of cGMP, contamination control, and safety regulations (OSHA, FDA, EU Annex 1).</li><li>Ability to read and interpret mechanical drawings, equipment manuals, and SOPs.</li><li>Familiarity with CMMS platforms and basic computer skills (e.g., Microsoft Office).</li><li>Self-motivated with strong attention to detail, problem-solving skills, and the ability to work independently or in a team.</li><li>Willingness to work flexible hours, including weekends or off-shifts during production or commissioning activities.</li></ul> Work Environment: <ul><li>Hands-on role in a regulated, sterile pharmaceutical manufacturing facility with strict safety and aseptic requirements.</li><li>Requires frequent gowning, standing, and work in confined or classified areas.</li><li>Fast-paced startup environment, requiring adaptability, initiative, and a collaborative mindset.</li><li>Occasional lifting of heavy tools or parts; use of ladders, lifts, and hand tools required.</li><li>Physical requirements include lifting climbing ladders, electrical troubleshooting, and working with hand and power tools</li></ul>

Overview: <ul><li>The Technical Support Manager leads a team of skilled mechanics and technicians responsible for the maintenance, troubleshooting, and reliability of facility infrastructure, clean utilities, laboratory systems, and pharmaceutical production equipment at our new injectable manufacturing site.&nbsp;</li><li>This individual will play a key leadership role in coaching, mentoring, and developing technical staff, while ensuring all maintenance activities are performed safely, efficiently, and in compliance with cGMP and regulatory requirements.&nbsp;</li><li>This is a pivotal role in a startup manufacturing environment, requiring strong leadership, technical depth, and a commitment to operational excellence and safety. During the start up phase this role will include the development of an asset management system and the development of standard operating procedures for the maintenance and calibration of systems across the plant.</li></ul> Responsibilities: <ul><li>Supervise and develop a team of mechanics and technicians supporting facilities, utilities, lab and production equipment. Additional oversight of contractors will be expected.</li><li>Coach, train, and mentor team to build technical depth and promote a culture of ownership and continuous improvement.</li><li>Lead the development of standard operating procedures as required.&nbsp;&nbsp;</li><li>Champion the start up and maintenance of an asset management system that will become the basis of technical support in the plant.&nbsp;&nbsp;</li><li>Lead daily planning, prioritization, and execution of maintenance and reliability activities.&nbsp;</li><li>Conduct performance reviews, skill assessments, and development planning for direct reports.</li><li>Lead the maintenance, calibration, and repair of critical systems including: HVAC, compressed air, WFI, clean steam, Nitrogen generation, isolators, fillers, automated inspection and leak detection equipment, automated secondary packaging equipment, lab systems, stability chambers, site infrastructure, and the Building Management System (BMS).</li><li>Ensure all activities are conducted in compliance with cGMP, safety regulations, maintenance plans and SOPs.</li><li>Support commissioning, qualification (IQ/OQ/PQ), and startup activities for new systems and equipment.</li><li>Drive proactive and preventive maintenance through and asset management system utilization and performance tracking.</li><li>Ensure good documentation practices and data integrity so all maintenance records are accurate, complete, and auditable.</li><li>Enforce a culture of safety focusing on EHS compliance, including Lockout/Tagout, confined space entry, Arc flash protection, and chemical safety protocols.</li><li>Support audits and inspections by regulatory agencies and internal quality teams.</li><li>Analyze equipment performance and maintenance data to identify trends, root causes, and opportunities to reduce downtime and increase reliability.</li><li>Collaborate with engineers, production, and quality teams to improve reliability and maintainability of equipment.</li><li>Manage spare parts strategy and implement inventory management process.&nbsp;</li></ul> Key Stakeholders: Internal: <ul><li>Site Leadership Team (Operations, Quality, Engineering, Warehouse, HR, Finance, EHS)</li><li>Manufacturing Teams</li><li>Validation and Project Management Teams</li></ul> External: <ul><li>FDA and other regulatory agencies</li><li>Third-party auditors and certifying bodies</li><li>External service providers such as calibration and maintenance service companies</li><li>Customers and business partners</li></ul> Requirements: Qualifications / Experience: <ul><li>Bachelor’s degree in engineering is required. Degree in Mechanical, Electrical, Biomedical, or similar preferred.</li><li>Minimum 5+ years of experience in pharmaceutical, biotech, or regulated manufacturing environment, with 2+ years in a supervisory or team lead role.</li><li>Strong technical knowledge of clean utilities, facility systems, secondary packaging and aseptic manufacturing equipment.</li><li>Experience supervising or mentoring maintenance personnel.</li><li>Experience working with a qualified asset management system.&nbsp;(Current system is SAP PM)</li><li>Experience in controlled substance and high potent product environment desired but not required.</li></ul> Skills / Competencies: <ul><li>Working knowledge of cGMPs, regulatory expectations, and CMMS systems (e.g., Blue Mountain, SAP PM, Maximo, etc.)</li><li>Strong organizational, communication, and leadership skills.</li><li>Demonstrated commitment to safety, compliance, and team development.</li><li>Excellent interpersonal, communication, and problem-solving skills.</li><li>Comfortable working in a fast-paced, evolving environment where agility and adaptability are key.</li><li>Strong leadership presence with demonstrated ability to build high-performing teams and compliance culture.</li><li>Effective communication, collaboration, and influencing skills across multiple stakeholders.</li></ul>

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5 utilities Jobs found

Principal R&D Innovation Engineer

Quality Engineer

Microbiology Technician

Facility Mechanic

Technical Support Manager

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5 utilities Jobs found

Principal R&D Innovation Engineer

Quality Engineer

Microbiology Technician

Facility Mechanic

Technical Support Manager

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