Senior Production Support Engineer – IDM Engineering (VP2)

Operator III, Packaging - 2nd Shift

Site Quality Leader

HR PARTNER II

EHS Analyst

Sales Engineer, Mining

Assistant Manager, SC Projects

Responsibilities: <ul><li>Engage in day-to-day support activities including incident and problem management</li><li>Perform production deployments, patch activities on the supported applications and servers.</li><li>Work with product support/development team for permanent resolution/change review – all types including enhancements, bug fixes, etc.</li><li>Work with level 1 support in application knowledge transfer in establishing standard first level recovery process/system health check monitoring/scheduled activities as well as common application user queries.</li><li>Collaborate with internal stakeholders like application, business, infrastructure, security, and operations to continuously improve the stability of applications.</li><li>Develop support operational documents to summarize common support issues.</li><li>Develop reports and drive audit RFI’s and requirements.</li><li>Develop Linux scripts based on the requirements.</li><li>Provide after office hours’ standby support and for emergency recoveries, including managing major incident of critical services.</li><li>Expected to drive improvements through influence and strong relationships with managers in other teams.</li><li>Correlate events across multiple systems to proactively surface and resolve deep, underlying issues.</li></ul> Requirements: <ul><li>Diploma/Degree in engineering/Computer Science / IT/Cyber Security from a recognized education institution</li><li>Professional qualification in information security, such as CISSP / CISM / CEH, or data Security product certifications will be advantageous.</li><li>9 to 12 years relevant experience</li><li>Strong working knowledge on Oracle Identity Governance 12c, Oracle Database, WebLogic, BI Publisher, Oracle Connectors, Linux, Unix &amp; Windows Enterprise Server OS, with mixed skills around administration, performance tuning and troubleshooting</li><li>Working knowledge of Python, java, Java Scripts,</li><li>Knowledge in network infrastructure like Load balancers, Firewalls, SSL etc</li><li>Working Knowledge on Directory - LDAP and AD Databases</li><li>Strong knowledge of Oracle SQL and proficient in writing complex SQL queries with hands on experience with reporting tools along with excellent computational ability.</li><li>Strong understanding of cybersecurity principles and frameworks including ISO 27001 &amp; NIST Cybersecurity Framework;</li></ul>

Role Description: <ul><li>With thorough knowledge and skills in all areas of the packaging process, performs more advanced functions relating to the packaging of drug products consistent with established Current Good Manufacturing Practices (cGMP), customer requirements and in conjunction with all Standard Operating Procedures (SOP). Is qualified in both Filling and Labeling. </li><li>Is qualified and capable of competently running all packaging equipment across the entire packaging department. </li><li>Responsible for the safe and efficient execution of their job duties, while ensuring product compliance to established standards. May serve as back-up to the Senior Packaging Technician.</li></ul> Responsibilities: Packaging Operations: <ul><li>Is qualified and capable of competently running all packaging equipment across the entire packaging department</li><li>Is qualified in both Filling and Labeling</li><li>Ensures that all equipment is running properly</li><li>Executes processes such as material handling, capping, outserts/med guides, in-process checks, packing, stacking, cartooning, etc.</li><li>May request components, labels and inserts per the BPR</li><li>Sets up packaging machinery; accurately sets equipment programming according to BPRs and SOPs</li><li>Sets up, starts, operates, adjusts, troubleshoots and tears down packaging lines</li><li>Executes Batch Production Record (BPR) and logbook documentation with detail and accuracy</li><li>Accurately reviews BPRs steps for completeness and accuracy</li><li>Collects samples from each batch and submits to QA for retained samples</li><li>Demonstrates the ability to execute procedures and complete tasks in a compliant and safe manner</li></ul> Equipment Cleaning: <ul><li>Conducts verification of line/equipment cleaning and documents per SOP</li><li>Executes the procedures used to clean pharmaceutical packaging equipment and facilities</li><li>Conducts Master Cleans and Surface Cleans</li></ul> Continuous Improvement : <ul><li>Identifies 6S opportunities and sustains the 6S process</li><li>Assists in troubleshooting process issues</li></ul> Issues and Deviations: <ul><li>Identifies and reports processing related issues to Packaging Supervisor and to Quality personnel.</li></ul> Quality: <ul><li>Executes the required in-process product quality checks and documents accurately.</li></ul> Teamwork and Collaboration: <ul><li>Demonstrates the ability to work in collaboration with others as a part of a team.</li></ul> Training: <ul><li>Stays current on SOPs and cGMPs.</li><li>May participate in training qualifier classes.</li></ul> Safety and Compliance: <ul><li>Participate in safety teams, start-up discussions, incident debriefs, etc.</li><li>Carries out processing/packaging activities safely, as required, on a daily basis.</li><li>Follows all safety and compliance procedures and participates in required training.</li><li>Adheres to all cGMP compliance/regulatory mandates and quality requirements.</li><li>Ensures compliance with SOPs, Policies and Procedures as required by Par and regulatory agencies</li></ul> Misc.: <ul><li>Other related duties as assigned to meet departmental and Company objectives.</li></ul> Requirements: Education &amp; Experience: <ul><li>High school diploma or equivalent.</li><li>3 years of packaging experience</li></ul> Knowledge &amp; Skills: <ul><li>Knowledge of cGMP regulations and processes.</li><li>Qualified in both Filling and Labeling</li><li>Qualified and capable of setting up and running all machinery in the value stream</li><li>Competent in Master Clean/Surface Clean</li><li>Ability to sample batches</li><li>Ability to follow both verbal and written instructions including SOP’s and Batch Record documentation</li><li>Ability to accurately and precisely record data and batch information</li><li>Ability to work in both independent and team environments</li><li>May become a certified trainer and provide certified training in one process</li><li>Effectively interfaces with other department personnel if Senior level (4th level) isn’t available</li><li>Ability to troubleshoot process issues</li><li>Ability to Identify 6S opportunities and sustain the 6S process</li><li>Ability to participate in Continuous Improvement projects</li><li>Proficient in reading and writing English to understand work instructions and document results</li></ul> Physical Requirements: <ul><li>Must be able to stand for long periods of time (8- or 12-hour shifts), lift at least 35 pounds, climb ladders, wear a dust mask or respirator and pass associated respirator tests and/or requirements, and be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes.</li><li>Dexterity - ability to quickly move your hand, your hand together with your arm, or your two hands to grasp, manipulate, or assemble objects.</li><li>Vision - ability to see details at close range (within a few feet of the observer).</li><li>Multi-limb Coordination - ability to coordinate two or more limbs (for example, two arms, two legs, or one leg and one arm) while sitting or standing.</li></ul>

Role Description: <ul><li>The Site Quality Leader is responsible for the administration, supervision, and development of the Wilsonville Quality Assurance and Quality Engineering functions.&nbsp;</li><li>This position is responsible for ensuring full compliance to the regulatory requirements of 21 CFR 820, ISO13485, MDR and other applicable regulations including production and process controls.&nbsp;</li><li>The Site Quality Leader will report to the Global Head of Quality Operations.</li></ul> Responsibilities: <ul><li>Ensure that Material Review Boards are in place to ensure products are appropriately dispositioned within a timely manner, while ensuring appropriate corrective and preventive actions are initiated and regulatory requirements are met.</li></ul>&nbsp;Develop and implement systems to assure that development as well as production teams receive support in the following areas: <ul><li>Quality planning, including inspection techniques and sampling methods</li><li>Statistical Analysis</li><li>Application of required regulatory standards</li></ul> Develop and implement procedures and systems to assure product manufactured for human use meets design and functional specifications. These systems are to include as a minimum: <ul><li>Delivery of raw materials and components</li><li>Manufactured devices and equipment</li><li>Documentation associated with these functions</li><li>Develop, track, and report on the following administrative systems:</li><li>Department metrics</li><li>Department objectives</li><li>Personnel development and training</li><li>Support regulatory agency and customer quality audits.</li><li>Ensure the conformity of the components and products are appropriately checked in accordance with the Quality Management System before release.</li><li>Responsible for assisting and training associates in concepts of probability and statistics.</li><li>Responsible for failure appraisal and analysis (internal and external).</li><li>Authority to place products or processes on hold.</li><li>Design and develop forms and instructions for recording, evaluating, and reporting quality data.</li><li>Corrective and Preventive Action program</li><li>Based on operational/quality requirements, assist in test equipment selection and validation.</li><li>Utilize formal problem solving techniques to resolve product and/or process related issues.</li><li>As required, lead cross-functional teams to support resolution of product and/or process related issues or objectives.</li><li>Work with suppliers of both raw materials and components, to improve product quality and/or resolve quality issues.</li><li>Be innovative, knowledgeable and intensely committed to ensure that every product and service we supply conforms to FDA and Quality System Regulations..</li></ul> Requirements: <ul><li>Bachelors Degree with a scientific or engineering emphasis.</li><li>ASQ Certified Quality Engineer recommended. Six Sigma Green/Black belt recommended.</li><li>7-10 years experience in a related regulatory environment.</li><li>Experience should include positions at senior levels within the medical device organizations.</li></ul>

Responsibilities: <ul><li>Understand business cycles and talent needs to develop and strengthen workforce capabilities aligned with business objectives.</li><li>Support recruiting and staffing initiatives and guide managers on compensation decisions.</li><li>Manage Family and Medical Leave Act (FMLA) and leave benefits through external program providers.</li><li>Facilitate and develop HR-related training and resources for managers to strengthen leadership and people management capabilities.</li><li>Support compensation and benefits administration, payroll, and salary management activities.</li><li>Align HR priorities with business unit strategies while balancing broader HR functional goals.</li><li>Maintain a positive and productive employee relations environment.</li><li>Drive a culture of continuous improvement and operational excellence.</li><li>Act as a change agent to support transformation initiatives, learning, and development programs.</li><li>Support employee engagement, culture initiatives, and inclusion &amp; diversity programs.</li><li>Partner with value stream managers and supervisors to develop employee training programs.</li><li>Ensure effective onboarding, orientation, and employee assimilation processes.</li></ul> Requirements: <ul><li>Bachelor’s degree in Human Resources or related field.</li><li>3–5+ years of experience as an HR Generalist within a manufacturing environment.</li><li>Prior plant/manufacturing site HR experience preferred with expertise in Employee Relations, Talent Acquisition, Coaching, and Development.</li><li>Experience working within cross-functional teams and influencing stakeholders.</li><li>Ability to manage ambiguity, risk, and shifting priorities.</li><li>Strong understanding of employment laws and HR best practices.</li><li>Proven experience in HR Operations, Compensation &amp; Benefits, Talent Management, Employee Relations, and Labor Relations.</li><li>Continuous improvement mindset with strong operational execution.</li><li>Strong strategic thinking and hands-on execution capabilities.</li><li>Excellent communication, facilitation, and presentation skills.</li><li>Ability to build trust and credibility across all organizational levels.</li><li>Strong interpersonal, organizational, analytical, and process-oriented skills with a strong sense of urgency.</li></ul>

Responsibilities: Planning; <ul><li>Initiate annual EHS training plan &amp; EHS internal audit plan in order to meet the department annual operating plan.</li></ul> Procedures &amp; Document Update; <ul><li>Review &amp; update EHS procedure according to internal &amp; external audit finding.</li><li>Initiate, update and execute EHS policies or procedures according to national laws and regulations or S.A.F.E or Global policies in order to fulfill company EHS system and make work efficient.</li></ul> Safety and Health Management: <ul><li>Submit application to Safety Bureau for Safety and Health Impact Assessment and other required permits or registration in order to meet the requirement of national laws and regulations.</li><li>Conduct Safety Standard Management review and follow in velocity EHS system.</li><li>Coordinate industrial hygiene monitoring, evaluation, medical surveillance in order to prevent occupational disease.</li><li>Maintain SAFE and environment tool with continuous improvement.</li><li>Follow up Incident investigation, correction and Injury Trend Analysis in order to prevent incidents.</li><li>Conduct canteen and dormitory inspection with Admin. to supervise food safety and fire safety,in order to prevent incidents.</li><li>Conduct contractor &amp; supplier EHS management, issuing non-routine high risk task permits, in order to prevent incidents.</li></ul> EHS Projects: <ul><li>Lead and follow up JSA, LOTO, Ergo, Machine Guarding,BBS, Nearhit reporting, PPE management, IH, Environmental and etc.</li><li>Coordinate the Kaizens and other EHS activities, in order to meet SAFE and 5 star requirement and prevent incidents.</li></ul> Audit; <ul><li>Implement routine EHS internal audit and examine;</li><li>Prepare necessary material or data sheet for S.A.F.E ,customer, local government, global audit;in order to ensure meet compliance requirements.</li></ul> Reporting &amp; Training: <ul><li>Prepare Monthly EHS performance report in order to present EHS performance;</li><li>Organize health and safety related training to employee in order to promote the awareness of health and safety."</li></ul> Requirements: <ul><li>Minimum 5+ years of EH&amp;S experience required;</li><li>Possesses a strong grasp of Malaysias EHS laws and regulations, EHS Greenbook,can conduct compliance assessments.</li><li>Autonomous ability in conducting audits and inspections of all aspects of EHS;</li><li>Good reading and writing in English &amp; Chinese</li><li>Skilled in leveraging Excel for data analysis, visualization, and tracking key metrics.</li></ul>

Responsibilities: <ul><li>Maintain contact with customers and ensure Company products are specified.</li><li>Achieve or exceed sales targets.</li><li>Identify design consultants and engineering contractors involved in projects with close and regular contact making us their preferred pump choice.</li><li>Identify upcoming projects and that the Pump Group specification is used.</li><li>Keep local and global team updated on projects by discussion and to maintain and progress projects.</li><li>Arrange and run customer training and presentations, which can be on-site and/or office based.</li><li>Feedback potential product improvements and complaints, where new applications offer greater potential but existing specifications exclude or lessen our suitability.</li><li>Increasing our market share by replacing other pump types as well as other manufacturers of peristaltic pumps.</li><li>Keep the Sales Manager updated with competitor activity encountered in the marketplace.</li><li>Identify, organize and progress field trials.</li><li>Identify and lead marketing activities maintaining our brand and finding new opportunities.</li><li>Keep CRM up to date with all customer activities.</li><li>Conduct all activities in accordance with the Quality Management System</li></ul> Requirements: <ul><li>Skilled negotiator to achieve sales targets.</li><li>Needs to work well with company co-workers, reps/distributors, and customers, and achieve desired results.</li><li>Ability to foster relationships with external institutes and organisations to promote interest in the use of our products</li></ul> Education and Experience Requirements: <ul><li>Minimum 5 years experience in mining sales.</li><li>Mechanical / Technical sales experience.</li><li>Experience in process engineering.</li><li>Advanced English writing/reading competencie</li></ul>

Role Description:&nbsp; <ul><li>We are hiring a Supply Chain Project Engineer to lead and manage engineering and CAPEX projects within a manufacturing environment.&nbsp;</li><li>This role involves working closely with global engineering teams and plant operations to deliver projects on time, within budget, and aligned with business goals.</li></ul> Responsibilities: <ul><li>Lead end-to-end project execution (design, installation &amp; commissioning).</li><li>Support technical proposals, cost estimation, and project planning.</li><li>Coordinate with suppliers, contractors, and cross-functional teams.</li><li>Supervise installation and construction activities on-site.</li><li>Ensure projects meet EHS, quality, and food safety standards.</li><li>Manage budget, timelines, and resource planning.</li><li>Work closely with global engineering, production, maintenance, and operations teams.</li><li>Support CAPEX planning and execution for plant initiatives.</li></ul> Requirements: <ul><li>Bachelor’s degree in engineering as Mechanical, Electrical or equivalent. MBA or Management degree is preferred.</li><li>Working with manufacturing environment is preferred. Minimum 4 years of engineering experience with minimum 3 years for project management.</li><li>Knowledge of mechanical, electrical and construction/structure are required. Also, good computer background is a must.</li><li>English communication skill is necessary in both speaking and writing.</li><li>Able to work with government officers and public organizations.</li><li>Knowledge of food industry and financial issues including CAPEX&nbsp;</li></ul>

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59 medical writing Jobs found

Senior Production Support Engineer – IDM Engineering (VP2)

Operator III, Packaging - 2nd Shift

Site Quality Leader

HR PARTNER II

EHS Analyst

Sales Engineer, Mining

Sales Engineer, Mining

Sales Engineer, Mining

Sales Engineer, Mining

Assistant Manager, SC Projects

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59 medical writing Jobs found

Senior Production Support Engineer – IDM Engineering (VP2)

Operator III, Packaging - 2nd Shift

Site Quality Leader

HR PARTNER II

EHS Analyst

Sales Engineer, Mining

Sales Engineer, Mining

Sales Engineer, Mining

Sales Engineer, Mining

Assistant Manager, SC Projects

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

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