Validation Manager

Process Equipment Engineer

Software Engineer, Quality Analyst

Responsibilities: <ul><li>Serve as the site Validation SME, overseeing all validation activities, including process, cleaning, equipment, utility, and computer system validation.</li><li>Own and maintain the Validation Master Plan (VMP), ensuring alignment with regulatory expectations, site activities, and company objectives.</li><li>Develop, implement, and maintain the site validation lifecycle program, including process validation, performance qualification (PQ), and CPV.</li><li>Lead validation planning and coordination efforts for new equipment, systems, and process changes in collaboration with Engineering, Manufacturing, and Quality.</li><li>Manage validation project timelines and resource allocation, ensuring activities support commercial readiness and ongoing operations.</li><li>Review and approve validation protocols, reports, and risk assessments in compliance with FDA, EMA, ICH Q8-Q10, EU Annex 15, and company standards.</li><li>Support and participate in cross-functional risk assessments (e.g., FMEA) related to qualification and validation efforts.</li><li>Ensure validation documentation is complete, accurate, and audit ready.</li><li>Provide guidance and technical expertise during regulatory inspections, audits, and customer assessments.</li><li>Develop and maintain the site’s Continuous Process Verification (CPV) program to monitor validated state and process performance over time.</li><li>Define and monitor KPIs for validation program effectiveness and drive improvements in validation efficiency and compliance.</li><li>Train and mentor staff on validation principles and procedures to build internal capability across departments.</li><li>Ensure change control, deviation management, and CAPA processes integrate appropriately with validation and qualification requirements.&nbsp;</li></ul> Key Stakeholders: Internal: <ul><li>Site Quality, Manufacturing, and Engineering Teams</li><li>Technical Services, Supply Chain, and EHS</li><li>Validation Analysts and Support Staff</li><li>Corporate Validation and Quality Teams</li></ul> External: <ul><li>Regulatory Agencies (FDA, EMA, etc.)</li><li>Equipment and system vendors</li><li>Contract testing laboratories</li><li>Third-party auditors and certifying bodies</li></ul> Requirements; Qualifications / Experience: <ul><li>Bachelor’s degree in engineering, Life Sciences, Pharmacy, or related discipline; Master’s preferred</li><li>Minimum 10-12 years of experience in pharmaceutical or biotechnology validation, with at least 3 years in a leadership or SME role</li><li>Validation of sterile injectable equipment expertise required</li><li>Strong knowledge of FDA cGMPs, ICH Q8–Q10, EU Annex 15, and validation best practices</li><li>Experience with sterile injectable manufacturing, aseptic processes, utilities, and equipment qualification</li><li>Experience with controlled substances and high-potency compounds preferred</li><li>Proven experience supporting regulatory inspections and third-party audits</li><li>Experience with commissioning, qualification, and validation in a startup (greenfield) or expansion environment preferred </li></ul> Skills / Competencies: <ul><li>Strong technical writing and documentation review skills</li><li>Ability to manage multiple projects and prioritize in a fast-paced environment</li><li>Expertise in sterile systems, process validation, cleaning validation, and computer system validation</li><li>Excellent cross-functional communication, influencing, and collaboration skills</li><li>Strong analytical, risk-based decision-making, and problem-solving skills</li><li>Leadership presence with ability to coach and mentor others in validation principles</li><li>Commitment to data integrity, patient safety, and product quality</li></ul>

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>Understand the test requirements and getting the team aligned with the same.&nbsp;</li><li>Participating on all technical aspects, interacting with client for all technical inputs and queries.&nbsp;</li><li>Automation and integration of complex processes.&nbsp;</li><li>Work closely with the development team on becoming the SME of the product.&nbsp;</li><li>Strong Testing Fundamentals , testing tools, reporting and frameworks.&nbsp;</li><li>Build and maintain the automation regression suite for the white box testing of the products.&nbsp;</li><li>Participate in requirement grooming and think form end customer perspective.&nbsp;</li><li>Should own all aspects of Testing, QA Framework for existing Products and Product end-to-end testing across functional, Security and Automation.&nbsp;</li><li>Work in a dynamic Agile environment and come up with solutions to meet project needs.&nbsp;</li><li>Communicate with Client and end customers in written and verbal.&nbsp;</li><li>Should be able to interact with client and customers for Escalated Customer Issues/Bugs.&nbsp;</li></ul> ﻿Requirements: <ul><li>Manual/Automation Testing - DataCom (Networking , Security, L2-L3, L4-L7 Protocols)&nbsp;</li><li>Hands on experience on Networking products Switch Router and Firewall&nbsp;</li><li>Good testing experience in Datacom/IP-Networking/Switching/routing domain.&nbsp;</li><li>Knowledge of Networking (L2/L3 protocols)&nbsp;</li><li>Knowledge of Testing tools : IXIA/SPIRENT&nbsp;</li><li>Security testing tool - Nessus, OpenVas, Achilles, Defensics (Anyone)&nbsp;</li><li>preferably knowledge / hands on in traffic generation tools such as IXIA or Spirent,&nbsp;</li><li>Performance and scalability testing, security, Penetration testing. packet sniffing tools.&nbsp;</li><li>Linux/containers Knowledge&nbsp;</li><li>Good understanding of testing concepts and hands-on experience in functional/sanity/regression testing.&nbsp;</li><li>CI/CD: Jenkins, GitHub, Bitbucket Actions&nbsp;</li><li>Scripting: Python and/or Shell is a must&nbsp;</li><li>Working experience in Routing protocols such as RIP, OSPF, BGP, MPLS VRRP&nbsp;</li><li>Good understanding of Management interface such as SNMP, Web, Yang, Netconf, Rest based interfaces etc&nbsp;</li><li>Good understanding of testing concepts and hands-on experience in functional/sanity/regression testing.</li><li>Strong written and oral communication skills.&nbsp;</li><li>High levels of motivation with a can-do attitude.&nbsp;</li></ul>

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Validation Manager

Process Equipment Engineer

Software Engineer, Quality Analyst

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3 sme Jobs found

Validation Manager

Process Equipment Engineer

Software Engineer, Quality Analyst

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

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