Specialist, Engineering

Job DescriptionSeeking candidates for a specialist position in the company's Research Laboratories (Research Division) Biologics Pilot Plant (BPP) supporting the Biologics Support Operations (BSO) Front-Line Managers.  The candidate will work under the director in a dynamic environment supporting compliance and operations objectives in aid of multiple pilot-scale campaigns for the GMP manufacture of bulk biologic (vaccines and therapeutic proteins) clinical supplies. Candidate will specifically support areas focusing on media and buffer manufacture, raw material weight and dispense, sterile tubing assembly and packaging, and GMP cleaning activities.Tasks:Candidate will participate in a range of activities including, but not limited to:Participate in or manage Quality Notification investigations and change management activitiesOrder process consumables used in GMP manufacturing activitiesSubmit requests for supply chains to Third Party Quality Management.Research and manage supplier notifications at the direction of the supplier notification lead.Prepare, Review, and update GMP Documentation (i.e. Standard Operating Procedures, Bills of Materials, Batch Records)Content expert and trainer for select proceduresData entry and electronic log creation and managementAssist with PAS-X administrative work (i.e. parameter value list (PVL) updates/ Change Controls/ Manufacturing Order (MO) creation, coordinating QA approval)Assist with warehouse coordination (i.e. scheduling sampling, risk release management, deliveries, SAP management)Assist with equipment troubleshooting and calibration coordinationWork with team members in identification and implementation of continuous improvement initiativesThis is a developmental role with an opportunity to build a foundation into a front-line manager position. Some overtime (including weekends) and occasional second shift work may be necessary. Carrying an on-call phone to support off-hour manufacturing will be required. Support safety, compliance, and GMP initiatives including conducting area walkthroughs and managing/closing observationsExperience/Skills:Comprehension of the regulatory guidelines governing GMP manufacture is required. The candidate will work in a team atmosphere in close partnership with (but not limited to) raw material release teams, facility operations, equipment engineering, process operations, safety, manufacturing division and quality groups.Education:BS/BA in Biological Sciences, Chemistry, Engineering or equivalent combination of education and experience Qualifications:Knowledge of current GMP regulationsWork both independently and in a team settingDemonstrated ability to manage multiple tasks and prioritiesEffective problem-solving skillsEffective technical communication skillsGood comprehension of Microsoft Office Applications, including SharePoint and Power Platform Tools Preferred:Knowledge of PAS-X Manufacturing Execution SystemKnowledge of SAP and Ariba order systemKnowledge of the Electronic Supplier Transparency Request systemKnowledge of ETQ Reliance system for supply chain notifications.Experience working within a Union EnvironmentHas worked in relevant manufacturing or processing (aseptic/sterile, bulk, solid oral dosage, packaging, etc.)Required Skills: Biological Sciences, cGMP Guidelines, GMP Compliance, Personal Initiative, Pilot Plant Operations, Process Engineering, Process Operations, Process Optimization, Product Formulation, Regulatory Compliance, Standard Operating Procedure (SOP) Writing, Sterile Manufacturing, Therapeutic ProteinsPreferred Skills: 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.As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:EEOC Know Your RightsEEOC GINA Supplement​We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.Learn more about your rights, including under California, Colorado and other US State ActsThe salary range for this role is$87,300.00 - $137,400.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.You can apply for