An amazing opportunity has arisen for a Technical Specialist. You will be a key team member of the Material Review Board (MRB) Team within the Technology Center of Excellence Department which provides technical expertise to a growing site with an expanding portfolio of technologies and products.You will deliver on timely implementations of Supplier Change Notifications by conducting detailed technical assessments of the change, while working collaboratively with all internal departments and external partners.What you will do: Bring energy, knowledge, innovation and leadership to carry out the following:Ensure highest Quality, Compliance and Safety standards are adhered to.Lead and manage suppler changes assigned. Ensure that key stakeholders both internal & external are kept informed throughout the change control lifecycle process.Conduct detailed technical assessments of materials and supplier changes from a Safety, Quality, Technical and Supply perspective and proactively manage the implementation of changes through the site change control process.Provide ongoing input and support to the MRB team members, support continuous process improvement initiatives, share their technical knowledge and promote best practices.Participate in problem solving teams as necessary.Support the building and fostering relationships with internal and external stakeholder`s.Responsible for actively participating in the Tier process to manage supplier changes and proactively manage and resolve issues before they impact the business priorities.What skills you will need:In order to excel in this role, you will more than likely have:4-5 years’ experience in a regulated manufacturing environment – ideally has worked in either in a technical / validation / process engineering positionDemonstrated Technical knowledge in pharmaceutical or Biopharmaceutical operations (e.g. manufacturing, technology, engineering, quality)Demonstrated understanding of the change control systems and processes in a regulated manufacturing environmentKnowledge of material qualification and / or supplier changes.Project Management skills and the ability to lead a project.Stakeholder management and management of multi decision makers in cross functional teams.Demonstrated capability to deliver results RFT, in an FDA / HPRA Regulated production environment.Demonstrated high level of problem solving and facilitation skills.Working proactively and collaborating across multiple functional teams.Experience dealing with external suppliers/ partners.As a company, we are committed to ‘Inventing for Life’ in all that we do.
We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs. 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.So, if you are ready to:Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.Current Employees apply HERECurrent Contingent Workers apply HERESearch Firm Representatives Please Read Carefully Merck & 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:NoTravel Requirements:No Travel RequiredFlexible Work Arrangements:Work WeekShift:Not IndicatedValid Driving License:Hazardous Material(s):Requisition ID:R151633