This job board retrieves part of its jobs from: Toronto Jobs | Emplois Montréal | IT Jobs Canada

Liberty and Prosperity for all - new job offers every day

To post a job, login or create an account |  Post a Job

Senior Specialist, Packaging Engineering, External Manufacturing

Merck & Co., Inc.

This is a Full-time position in Rahway, NJ posted July 18, 2021.

Job DescriptionOur Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.This is a packaging generalist position and the incumbent will be responsible for leading and supporting the technical interface with external packaging partners. These partners are Contract Manufacturing Organizations in the External Manufacturing (ExM) space. The incumbent collaborates with other functions (Quality, Operations, Supply Chain, Procurement) and specialist centers of excellence in the Science & Technology network where needed.Working under general scientific and administrative direction, this packaging engineer leverages experience gained on scientific, technical, and business issues, to lead and support the technical interface between our Company and packaging project teams and advise technical staff to solve complex packaging problems. The ability to apply these in a fast-paced Technical Operations environment to resolve issues and meet customer needs in a compliant manner are at the core of this position. The incumbent generates and analyzes scientific data, reports the resulting information, and captures and disseminates knowledge in standard format for current and future use. The position requires advanced knowledge, skills, and abilities to create and optimize technical, operation and compliance processes. Effective leadership of, or collaboration with, high-impact, complex cross-functional and cross-divisional teams and initiatives is needed.Some key areas of responsibility include:* As part of the ExM Packaging Focus Factory team, establishing a calibrated technical oversight approach based on the product type, as well as the capabilities and technical competence of an external partner;* Technology transfers, Qualifications, Validations, Process Improvements, and Change Control;* Assurance of compliant packaging process execution and project management;* Functioning independently and providing coordination, communication, and oversight on all technical matters pertaining to the external packaging partners;* Technical aspects of fact finding around quality and supply investigations, including leading root cause analyses and developing robust preventive actions;* Significant experience with packaging operations support, packaging development, packaging materials, packaging equipment and packaging processes;* Supporting technical due diligence assessments;* Assuring technical site readiness for all new product introductions or technology transfers;* Participating in periodic Business Review Meetings with external packaging partners;* Leading complex changes of packaging images and primary, secondary, and tertiary materials;* Qualification of changes to distribution and thermal transport/storage systems and methods for finished drug products;* Qualification of functional aspects of container closure systems, such as Child Resistance.Education Minimum Requirement:* BS degree in Packaging Science, Mechanical Engineering, Chemical Engineering, Materials Science, or similarRequired Experience and Skills:* 8+ years of experience in a regulated environment.* 5+ years of hands-on experience with packaging operations support, packaging materials/components, and packaging processes.* 2+ years of experience in a pharmaceutical site or External Manufacturing role (Operations, Technology, or Quality).* Knowledge in the regulations of major markets in the Pharmaceutical industry, e.g. USFDA cGMPs, EMA.* Project management skills, from conception and initiation, through close-out.* Significant experience with packaging operations support, packaging materials/ components, and packaging processes.* Experience using quantitative decision tools for Risk Management and options analysis.* Completes activities with the highest regard for all Company divisional and local site procedures for safety, quality, and regulatory compliance.* Excellent oral and written communication skills* Proven ability to provide technical leadership and apply technical skills in a fast-paced, complex environment.* In depth understanding and proven expertise in application of Good Manufacturing Practices (GMP’s), quality systems, especially technical subsystems related to process and equipment qualification, change control, deviation management and cleaning qualification.* General understanding of the relevant scientific/ technical concepts to execute routine and increasingly complex tasks; advanced working knowledge in the relevant scientific /technical techniques and is able to apply those techniques to routine and increasingly complex task.* Strong analytical skills and decision-making skills.* Demonstrates Leadership Behaviors and Inclusive Behaviors.Preferred Experience and Skills:* Experience with parenteral packaging.* Experience with combination product packaging.* Demonstrated deep technical skills in the area of packaging operations.* Experience with key manufacturing compliance and business systems: Trackwise change owner, MIDAS, SAP, Tracelink.Experience leading technical transfers.Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high quality, reliable supply to customers and patients on time, every time.Who we are …We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.What we look for …In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.NOTICE FOR INTERNAL APPLICANTSIn accordance with Managers’ Policy – Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.Current Employees apply HERECurrent Contingent Workers apply HEREUS and Puerto Rico Residents Only:Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.For more information about personal rights under Equal Employment Opportunity, visit:EEOC PosterEEOC GINA SupplementOFCCP EEO SupplementPay Transparency NondiscriminationWe are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.Search Firm Representatives Please Read CarefullyMerck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.Employee Status:RegularRelocation:No relocationVISA Sponsorship:Travel Requirements:Flexible Work Arrangements:Remote Work, TelecommutingShift:Valid Driving License:Hazardous Material(s):Number of Openings:1