Senior Specialist, Engineer - Project/Validation

Job DescriptionNew hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.Our 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. Position Description: Reporting to the Associate Director, the Senior Specialist, Project/Validation Engineer is accountable for the delivery of end-to-end capital projects to the Bottle/Blister/Vaccine Integrated Production Teams while determining the best method for providing optimum performance in manning, equipment, systems, documentation, and asset utilization.The basic function of this position is to, independently or as part of a project team, plan, design and implement varied technical projects and studies requiring knowledge of engineering and/or pharmaceutical sciences. This role requires expertise and full application of sound scientific principles, theories, concepts, techniques, and project management skills, as well as working knowledge of our Company methods, standards, procedures, and practices. The role is expected to collect and interpret information, to develop solutions and to make decisions with high liability to projects of varying scopes. The Senior Specialist, Project/Validation Engineer will participate and drive planning, design, and implementation of capital projects including scope generation, process & facility design, equipment selection, vendor interaction, factory acceptance testing, support - technology transfer, construction support, equipment qualification, facility start-up and process demonstrations.Expertise in qualification and process validation practices for complex systems is essential to success in this role with very minimal supervision, guidance, and direction. The successful candidate will be energetic and technically sound, with strong interpersonal, communication, and partnership skills accountable for executing FAT, IQ, OQ and PQ for equipment and systems supporting the Wilson Packaging Operation. This candidate will also provide leadership and training to others.Responsibilities:Capital project support to include cost estimation, business case, budget, schedule, design, procurement, installation, commissioning, start-up, troubleshooting, qualification, and documentation compliant with cGMP regulations and company engineering standards.Develop and maintain project/portfolio dashboard for tracking progress and communicating updates / escalations.Coordinate scope, assign tasks and allocation of resources within a cross- functional team to meet project goals and deadlines. Foresee possible risks and produce preventive solutions.Partners and engages with multiple functional organizations such as Operations, Technology, Quality, Automation, Global Engineering Services, Procurement, Finance, Above Site Technology, Regulatory, among others, to develop and maintain processes that meet cGMP and business requirements.Contribute to process and equipment safety reviews.Review literature pertaining to pharmaceutical packaging to introduce new profitable/productivity ideas into the packaging operation.Participate in the equipment specification, selection/procurement, and qualification phases of capital projects.Author, review, and/or edit validation documents and SOPs.Support Change Control documentation for complex process, validation, analytical, equipment, facility/utility and/or automation changes.Lead validation topics in regulatory inspections by presenting and defending validation documentation.Maintain alignment with internal technical personnel regarding validation practices for products, processes, and equipment.Manage consultant engineering firms as well as mechanical and electrical installation contractors in a production environment.Provides technical assistance to packaging operations in the resolution of processing problems for in-line products as required.Serve as site serialization lead.Mentor less experienced engineers, assisting with technical development.Position Qualifications: Education Minimum Requirement: Bachelor's degree in relevant engineering discipline (e.g., chemical, mechanical, electrical) and a minimum of 6 years of relevant industrial experience.Masters degree in relevant engineering discipline (e.g., chemical, mechanical, electrical) and a minimum of 4 years of relevant industrial experience.Required Experience and Skills: Demonstrated Project Management Experience, preferably in regulated industrial setting.Validation experience applying GAMP5/ASTM-2500E qualification/verification standards.Serialization systems (i.e., Systech).Pharmaceutical manufacturing within a current Good Manufacturing Practices (cGMP) environment.Authoring technical documentation within a current Good Manufacturing Practices (cGMP) context.Demonstrated effective written and verbal communication skills.Project strategic plan development and management.Demonstrated ability to work both independently and as a part of a team.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., Rahway, 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 ... Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us-and start making your impact today.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.For positions located in the United States and Puerto Rico - Subject to applicable law, all new hires (including internal transfers) must demonstrate that they are fully vaccinated against COVID-19 or that they qualify for a medical or religious exemption to this vaccination requirement. New hires (including internal transfers) to a position that, as determined by the Company, requires routine collaboration with external stakeholders (such as roles in health services or customer-facing commercial or research-based roles) ("Customer-Facing Role") who are not vaccinated must qualify for a medical or religious exemption and be in a position that the Company determines can accommodate unvaccinated employees without causing an undue burden to business operations. If, following dialog with the candidate as appropriate, it is determined that the candidate either a) does not qualify for a religious or medical exemption or, b) for candidates applying for Customer-Facing roles, it is determined that allowing the candidate to work without vaccination would cause an undue burden to the Company, the candidate will be ineligible for hire or transfer, or any offer of employment or transfer (if applicable) will be revoked. Please note that notwithstanding the approval of any reasonable accommodation, the Company reserves the right to monitor, modify, or revoke any such accommodation if it is determined, following dialog with the employee, that the accommodation is no longer effective or results in an undue burden to the Company.Current Employees apply HERE Current Contingent Workers apply HERE US 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 Poster EEOC GINA Supplement OFCCP EEO Supplement Pay Transparency Nondiscrimination We 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. Residents of Colorado: Click here to request this role's pay range. Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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:DomesticVISA Sponsorship: Travel Requirements: Flexible Work Arrangements:Shift:1st - DayValid Driving License:Hazardous Material(s):Number of Openings: 1