Associate Director RA & QA

Lead IT Business Consultant Service - D365

Facility Engineering - Electrical / Mechanical

Lead Field Service Engineer - Power Generation

Manufacturing Engineer - Electrical

Maintenance Engineer

Role Description: <ul><li>The Associate Director – Regulatory Affairs (CA) will lead the development and execution of regulatory strategies to support the timely approval, lifecycle management, and commercialization of generic pharmaceutical products in Canada. </li><li>The role will focus heavily on Abbreviated New Drug Submissions (ANDS) and Supplemental ANDS filings, while acting as the primary interface with Health Canada for regulatory discussions, clarifications, and negotiations.</li><li>This position plays a critical strategic role in new product development, portfolio expansion, and in-licensing evaluation, ensuring all regulatory activities align with Health Canada requirements, corporate objectives, and market access timelines.</li><li>The Director will also support portfolio maximization (PMX) initiatives, identify regulatory opportunities, and oversee a small regulatory team.</li></ul> Responsibilities: Regulatory Strategy &amp; Leadership <ul><li>Develop and implement regulatory strategies for ANDS submissions to Health Canada that maximize probability of approval and accelerate time to market.</li><li>Provide strategic regulatory guidance during product selection and development phases, including formulation, bioequivalence, and labeling strategy.</li><li>Ensure regulatory considerations are integrated into R&amp;D, clinical, CMC, and commercial planning.</li><li>Advise senior leadership on Canadian regulatory landscape, evolving guidelines, and approval pathways.</li><li>Lead regulatory planning for first-to-file, complex generics, and niche opportunities where applicable.</li></ul> Health Canada Engagement &amp; Regulatory Submissions <ul><li>Serve as the primary liaison with Health Canada, maintaining professional and proactive relationships with regulatory authorities.</li><li>Lead preparation and submission of: o Abbreviated New Drug Submissions (ANDS)</li><li>Supplemental ANDS (SANDS)</li><li>Notifiable Changes</li><li>Post-approval regulatory filings</li><li>Manage Health Canada deficiency responses, clarification requests, and review cycles.</li><li>Coordinate cross-functional teams to ensure high-quality regulatory dossiers</li><li>Represent the company in Health Canada meetings, scientific advice discussions, and regulatory negotiations.</li><li>Track and interpret Health Canada guidance updates, policy changes, and regulatory precedents affecting generic drug approvals.</li></ul> In-Licensing &amp; Regulatory Due Diligence <ul><li>Conduct regulatory due diligence for potential in-licensing and partnership opportunities.</li><li>Evaluation of regulatory pathways and submission feasibility</li><li>Data package completeness</li><li>Bioequivalence strategy</li><li>Intellectual property and exclusivity considerations</li><li>Estimated approval timelines and risks</li><li>Provide regulatory risk assessments and strategic recommendations to senior management during deal evaluation.</li><li>Support technology transfer and regulatory integration of licensed products into the company’s Canadian portfolio.</li></ul> Portfolio Management &amp; Lifecycle Optimization <ul><li>Support portfolio maximization (PMX) initiatives, including o Label expansions</li><li>New strengths and dosage forms</li><li>Site transfers</li><li>Manufacturing changes</li><li>Competitive lifecycle strategies</li><li>Identify regulatory opportunities to extend product lifecycle or improve market competitiveness.</li><li>Partner with commercial, market access, and supply chain teams to align regulatory activities with business objectives.</li></ul> Cross-Functional Collaboration <ul><li>Work closely with internal teams including o R&amp;D / Formulation Development</li><li>Clinical &amp; Bioequivalence</li><li>Quality Assurance / Quality Control</li><li>CMC / Manufacturing</li><li>Intellectual Property</li><li>Business Development</li><li>Provide regulatory input during product development milestones and technical reviews.</li><li>Ensure regulatory compliance with Health Canada, ICH, and global regulatory standards.</li></ul> Team Leadership &amp; Development <ul><li>Lead, mentor, and develop 1–3 regulatory associates/managers.</li><li>Oversee work allocation, submission timelines, and performance development.</li><li>Build a high-performance regulatory function capable of managing increasing submission volume.</li><li>Promote a culture of accountability, quality, and regulatory excellence.</li></ul> Requirements: Education &amp; Experience <ul><li>Advanced degrees in Pharmacy, Life Sciences, Pharmacology, Regulatory Affairs, or related discipline.</li><li>Regulatory certification (e.g., RAC) is considered an asset.</li><li>15–20 years of regulatory affairs experience within the pharmaceutical industry.</li><li>Extensive experience with Canadian regulatory submissions, particularly:</li><li>ANDS</li><li>SANDS</li><li>eCTD filings</li><li>Demonstrated experience interacting directly with Health Canada.</li><li>Strong understanding of Generic drug approval pathways</li><li>Bioequivalence requirements</li><li>CMC regulatory expectations</li><li>Experience supporting business development or in-licensing regulatory evaluations.</li><li>Previous team leadership or mentoring experience preferred.</li></ul> Core Competencies <ul><li>Strategic Thinking Ability to translate regulatory requirements into business-focused strategies that accelerate approvals and strengthen the company’s competitive position.</li><li>Regulatory Expertise Deep knowledge of Health Canada regulatory frameworks, ANDS requirements, and generic drug approval processes.</li><li>Stakeholder Influence Proven ability to engage effectively with regulatory authorities, internal leadership, and external partners</li><li>Physical Requirements</li></ul> Physical &amp; mental requirements: <ul><li>Business travel (15% of time), driving as part of work responsibilities.</li></ul>

Responsibilities: Lead Consultant Responsibilities <ul><li>Provide oversight and ensure solutions align with the broader business architecture, avoiding siloed approaches.</li><li>Ensure modifications to shared functionalities are evaluated holistically to avoid conflicting changes.</li><li>Establish and enforce best practices, including clear documentation, intuitive configurations, and optimized parameter settings.</li><li>Challenge business requirements to ensure cost-effective and value-driven solutions.</li><li>Harmonize design across multiple consultants, teams, and projects to enhance consistency and efficiency.</li></ul> Work closely with the ERP Solution Architect to ensure: <ul><li>Alignment with Microsoft’s roadmap and strategic ERP direction.</li><li>Architectural consistency across process areas and technical solutions.</li><li>Risk assessment for system-critical modifications.</li><li>Data migration strategies align with the overall system architecture.</li><li>Identification and resolution of conflicts with other processes, modifications, or upcoming Microsoft updates.</li></ul> Service-Specific Responsibilities <ul><li>Lead solution delivery for Service processes based on D365 Finance and Operations modules, covering:</li></ul> <ul><li>Project Management and Accounting module</li><li>HSO Service Management module</li><li>Intercompany chain</li><li>Sales orders and Return orders management</li><li>Advanced Warehousing (incl. Batch and Serial tracking)</li><li>Act as the primary owner and project lead for Service-related ERP implementations and enhancements.</li><li>Analyze business needs and develop solution concepts.</li><li>Design, configure, and document ERP solutions.</li><li>Provide detailed requirements for the development team.</li></ul> Requirements: <ul><li>Extensive experience (min. 5 years) as a Microsoft D365 ERP F&amp;O IT Consultant with a focus on Service.</li><li>Agile mindset and ability to work independently.</li><li>Strong analytical and problem-solving skills, with the ability to think critically under pressure.</li><li>Excellent communication skills, capable of engaging with stakeholders at all levels.</li><li>Leadership skills, including the ability to mentor consultants and drive best practices across teams.</li><li>Fluent in English.</li></ul>

Responsibilities: Operate &amp; Maintenance <ul><li>Leads safe, compliant operation and maintenance of electrical infrastructure, establishes and controls MOS/SOP with strong change management, maintains accurate technical documentation, partners with Engineering, Operations, and EHS on regulatory compliance, drives risk and safety programs (FMEA, LOTO, arc flash, permits), and ensures full standards compliance and audit readiness.</li></ul> Reliability &amp; Risk Management <ul><li>Drives root cause analysis for electrical disturbances, leads predictive and preventive maintenance programs, and strengthens system reliability to minimize unplanned downtime.</li></ul> Capacity Planning &amp; Tool Install <ul><li>Plans and manages electrical load models across fab and facilities operations, ensures proper feeder loading, redundancy, and diversity, and reviews/approves designs while overseeing safe energization and commissioning.</li></ul> Projects &amp; Commissioning <ul><li>Define acceptance criteria, test protocols, and witness critical tests.</li><li>Manage vendor performance and ensure documentation close out (O&amp;Ms, as builts).</li></ul> Power Quality &amp; Energy Performance <ul><li>Monitor PQ and deploy mitigations (filters, SEMI F47 ride through, UPS tuning).</li><li>Drive energy efficiency projects (e.g., transformer loading optimization, UPS efficiency, busway losses, smart metering analytics).</li></ul> Requirements: <ul><li>At least a Bachelor’s degree in Electrical Engineering or equivalent.</li><li>Minimum 6 years of related work experience in Electrical Engineering within wafer fab/semiconductor</li><li>Experience in high volume manufacturing of electronics components in an MNC or semi-conductor industry.</li><li>Direct working experience in wafer fab facilities will be added advantage.</li><li>Possess strong technical competencies in his field of study.</li><li>Able to work under pressure and with strong commitment at work.</li><li>Experience with software applications such as MS Power Point, Excel and Word.</li></ul>

Role Description: <ul><li>Lead Field Service Engineer – Power Distribution Location: Spain Region Covered: EMEA Work Model: Hybrid / Field-based Travel: Up to ~50% across Europe</li><li>Role Overview We are hiring a senior Lead Field Service Engineer with deep technical expertise in Medium Voltage (MV) power distribution and switchgear systems.</li><li>This is a technical lead role supporting large-scale data center and critical infrastructure projects across Europe.</li><li>This is not a people management role, but a technical authority position supporting and guiding other field engineers on complex installations and commissioning activities. Required Technical Experience.</li><li>Strong hands-on experience with Medium Voltage switchgear and distribution systems.</li><li>MV mechanical installation and commissioning experience.</li><li>Experience with MV testing and commissioning tools (e.g., Omicron, Megger, T&amp;R, Fluke or similar) Protection relay and control scheme testing knowledge.</li><li>Experience creating SAT test plans and commissioning procedures.</li><li>Ability to interpret electrical drawings and protection schemes.</li><li>Experience with interlocking, inter-tripping, blocking, and I/O testing.</li><li>Background in data center, critical power, or large industrial electrical projects.</li></ul> Responsibilities: <ul><li>Lead installation, commissioning, testing, and maintenance of MV power distribution and switchgear equipment.</li><li>Execute site acceptance testing (SAT) and commissioning test plans.</li><li>Perform MV electrical testing and functional verification.</li><li>Act as primary technical point of contact during project execution.</li><li>Support and guide field service engineers on complex technical issues.</li><li>Review drawings, schemes, and specifications and flag gaps or risks.</li><li>Prepare RAMS (risk assessments and method statements).</li><li>Ensure strict adherence to electrical safety and LOTO procedures.</li><li>Support project managers to ensure delivery within timelines.</li><li>Interface with customers during installation and commissioning phases.</li><li>Deliver technical demonstrations and customer witness testing.</li></ul> Requirements: Preferred Qualifications: <ul><li>Electrical Engineering qualification or equivalent experience.</li><li>Typically 10+ years of relevant field service / commissioning experience Skills &amp; Competencies.</li><li>Strong troubleshooting and decision-making ability.</li><li>Technical leadership mindset</li><li>High safety awareness culture.</li><li>Strong customer-facing communication skills.</li><li>Ability to work independently on complex sites Willingness to travel extensively across EMEA Language.</li><li>English — required&nbsp;</li><li>Spanish — preferred but not mandatory</li></ul>

Role Description: <ul><li>Seeking a skilled Electrical &amp; Electronics Engineer to manage the electrical/ electronics infrastructure, control systems, and automation for our electroplating operations, ensuring optimal performance, quality, and safety in a fast-paced manufacturing environment.</li></ul> Responsibilities:&nbsp; <ul><li>System Design &amp; Implementation: Install electrical systems, schematics, and controls for plating lines (rectifiers, heaters, pumps, automation).</li><li>Automation &amp; Control: Program, troubleshoot, and maintain PLC, SCADA, and HMI systems for automated plating processes, ensuring consistency and efficiency.</li><li>Power Management: Manage high-current DC power supplies (rectifiers) and associated distribution systems for plating baths</li><li>Maintenance &amp; Troubleshooting: Perform preventative maintenance, diagnostics, and rapid resolution of electrical faults in plant equipment and control systems.</li><li>Safety &amp; Compliance: Ensure all electrical installations and operations meet strict safety standards, codes and environmental regulations.</li><li>Process Optimization: Analyze electrical data to improve plating quality, efficiency, and cost-effectiveness, working closely with Plating Engineers/Mechanical engineers/chemists.</li><li>Documentation: Create and maintain detailed technical documentation, including electrical line diagrams, BOMs, and test reports.</li><li>Collaboration: Work with mechanical engineers, production staff, and vendors on project execution and system upgrades.</li></ul> Requirements: <ul><li>Education: Bachelors degree in Electrical &amp; Electronics Engineering.</li><li>Experience: Proven experience in industrial automation, power electronics, or electroplating operations.</li><li>Technical Skills: Strong knowledge of PLCs, HMIs, VFDs, and industrial control systems.</li><li>Proficiency in reading electrical drawings, schematics, and blueprints.</li><li>Understanding of power electronics (rectifiers) and DC power systems. o	Familiarity with plating processes (e.g., Nickel, Zinc, Chrome) and associated chemicals.</li><li>Knowledge of safety standards for electrical systems in industrial environments.</li><li>Soft Skills: Excellent problem-solving, analytical, leadership, and communication skills.</li></ul>

Role Description:&nbsp; <ul><li>To lead and manage Electrical, Electronics, PLC, and Mechanical maintenance activities across processing and packing assets.&nbsp;</li><li>The role is responsible for ensuring safe, reliable, and efficient operation of equipment by eliminating electrical, automation, mechanical, and process-related. breakdowns, improving equipment reliability and OEE, and strategically reducing unplanned downtime through effective maintenance execution and team leadership.&nbsp;</li></ul> Responsibilities: <ul><li>Lead, coordinate, and manage both Electrical and Mechanical Maintenance teams.&nbsp;</li><li>Provide hands-on technical leadership for electrical, electronics, PLC, and mechanical breakdowns.&nbsp;</li><li>Manage preventive, corrective, and condition-based maintenance activities across all processing and packing equipment.&nbsp;</li><li>Troubleshoot PLC-controlled systems including fault diagnostics, I/O checks, sensors, actuators, and basic logic analysis.&nbsp;</li><li>Oversee mechanical maintenance activities including rotating equipment, conveyors, gearboxes, bearings, and drive systems.&nbsp;</li><li>Guide maintenance teams in root cause analysis (RCA), loss analysis, and implementation of permanent corrective actions.&nbsp;</li><li>Ensure effective maintenance planning, execution, and reporting through SAP PM.&nbsp;</li><li>Own and maintain electrical, automation, and mechanical spare parts inventories, ensuring availability of critical spares.&nbsp;</li><li>Develop maintenance standards, work instructions, and OPLs for electrical, PLC, and mechanical activities.&nbsp;</li><li>Support technician capability development through coaching and technical training (electrical, PLC, and mechanical).&nbsp;</li><li>Ensure compliance with EHS, QFS, and machinery safety standards during all maintenance activities.&nbsp;</li><li>Maintain accurate documentation and records to support internal and external audits (EHS, QFS, KWS, FSSC, etc.).&nbsp;</li></ul> Key Performance Indicators (KPIs):&nbsp; <ul><li>Reduction of unplanned downtime.&nbsp;</li><li>Improvement of equipment reliability and OEE.&nbsp;</li><li>Preventive maintenance on-time completion rate.</li><li>Breakdown response time and MTTR.&nbsp;</li><li>Maintenance cost control and spare parts availability.&nbsp;</li><li>Electrical and Mechanical team capability development.&nbsp;</li></ul> Requirements: <ul><li>Bachelor’s degree in Electrical &amp; Electronics Engineering or Mechatronics Engineering.&nbsp;</li><li>Minimum 5 years of maintenance experience in manufacturing or FMCG environments.&nbsp;</li><li>Proven experience in leading both electrical and mechanical maintenance teams.&nbsp;</li><li>Strong knowledge of industrial electrical, electronic, automation, and mechanical systems.&nbsp;</li><li>Mandatory PLC knowledge : - Fault finding and diagnostics - I/O modules, field devices, and communication basics - Ability to read and analyze PLC logic&nbsp;</li><li>Solid mechanical knowledge including rotating equipment, gearboxes, bearings, conveyors, and power&nbsp;transmission systems.&nbsp;</li><li>Experience with motors, inverters, servo drives, sensors, actuators, and control systems.&nbsp;</li><li>Experience with SAP PM or similar CMMS systems.&nbsp;</li><li>Strong leadership, problem-solving, communication, and decision-making skills.</li></ul>

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Associate Director RA & QA

Lead IT Business Consultant Service - D365

Facility Engineering - Electrical / Mechanical

Lead Field Service Engineer - Power Generation

Manufacturing Engineer - Electrical

Maintenance Engineer

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6 o Jobs found

Associate Director RA & QA

Lead IT Business Consultant Service - D365

Facility Engineering - Electrical / Mechanical

Lead Field Service Engineer - Power Generation

Manufacturing Engineer - Electrical

Maintenance Engineer

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

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