Job Description

DescriptionThe Enabling Facilities (EF) group within the Chemical Engineering Research & Development (CERD) Department is seeking a highly motivated individual to work in a fast-paced job that provides a high degree of technical and project management responsibility. The Associate Specialist \xe2\x80\x93 Process/Facility Engineering position will report to the Director, Engineering and will be a member of the EF Team at the Rahway, NJ facility. EF is responsible for development of new technologies/capabilities, execution of capital and non-capital improvement projects, and interfacing with the automation system assets spanning production, utility systems and associated infrastructure. Responsibilities of the Associate Specialist \xe2\x80\x93 Process/Facility Engineer include the following:The process engineer role at the Associate Specialist level will serve as a process team member supporting the Modality Agnostic Chemistry Scaleup (MACS) Center. This is a new potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned in Rahway, New Jersey. They will serve as a team member of the MACS Center Basis of Design Phase and will go on to support new and/or existing facilities across the Small Molecule Process Research & Development (SM PR&D) network.As the facility is currently under construction, the selected candidate will contribute to equipment and facility design, system commissioning/qualification, as well as other critical activity workstreams to enable facility startup. The selected candidate is expected to be a key part of a team of process/facility engineers and foster a culture of collaboration, learning and innovation.They will collaborate closely with the development engineers & chemists, compliance representatives, and other team members to ensure the quality and safe delivery of clinical supplies, the scientific rigor of the processes, and ultimately to enable flexibility and speed of the Company\xe2\x80\x99s pipeline. This role may support facility operations, process development activities, support compliance investigations/change management, author GMP documentation and manage/lead engineers in any of our enabling facilities.Additional Supported AreasAs required and in addition to support of current capital projects the Associate Specialist may provide direct support to other areas such as:Small Scale Organics Pilot Plant (SSO): The SSO is a Good Manufacturing Practice (GMP) manufacturing facility in the Process Research and Development (PR&D) organization. The pilot plant\xe2\x80\x99s mission is to serve as PR&D\xe2\x80\x99s internal node for small molecule drug substance clinical manufacture, and as preferred site for first pilot of commercial small molecule processes, enabling gain of critical internal experience with scale-up of manufacturing GMP steps, demonstration of new manufacturing technology/processes, training opportunities for improved manufacturing process development and seamless tech transfer to commercial sites.Prep Lab Area: The Prep Lab is used to generate data which contributes to process definition and provides Phase I/II clinical material when needed. This kilo scale capability establishes reaction parameters and ensures successful batches when transferring to pilot scale. Areas of the Prep Lab have been and are continuing to be upgraded to support pipeline programs such as ADCs, PDCs, and other cross modality compounds that require a more flexible potent compound processing space.Education Minimum Requirement:Bachelor\xe2\x80\x99s degree in Chemical Engineering, Chemistry, Biology, Pharmaceutical Sciences or related scientific field.Required Experience and Skills:Effective interpersonal and communication skills, both verbal and written.Excellent organizational skills to multi-task.Desire and willingness to learn, contribute and lead.Track-record of independent problem-solving.Strong communication skills to discuss technical problems and a collaborative mindset to interface with cross-functional teams.A strong mechanical aptitude.Proficiency in technical writing and the use of word processing, spreadsheet, graphing, and presentation software.Desired Experience and Skills:Experience working in a GMP clinical or manufacturing supply facility.Experience with GMP facility design, equipment start-up and/or qualification.Experience with small molecule drug substance and/or biologics process development.Experience in supporting compliance investigations and change management.Familiarity with US and EU GMP and Safety compliance regulationsAbility to convert new drug substance process needs to an executable series of steps and procedures to enable acceptable product manufacture.Ability to prepare Standard Operating Procedures (SOP) and cGMP documents.Experience operating/maintaining pilot scale or prep lab scale equipment.Experience in Process Hazard Analysis (PHA) and/or Level of Protection Analysis (LOPA)Experience providing technical mentorship.Experience with Potent Compound processing and containment systems (e.g., isolators).Experience with Quality systemsExperience interacting with or overseeing the management of process utility system associated with a large drug substance pilot plant including WFI generation/distribution, Process Chillers, Vacuum Systems, etc.Experience working in an environment with an Automation System (DeltaV, PLC, etc.).Experience with coordinating maintenance activities around processing activities to support reliable facility operation.NOTICE FOR INTERNAL APPLICANTSIn accordance with 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 separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.Current Employees applyCurrent Contingent Workers applyUS 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 if you need an accommodation during the application or hiring process.We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: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\xe2\x80\x99s thinking and approach problems collectively.U.S. Hybrid Work ModelEffective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as \xe2\x80\x9cremote\xe2\x80\x9d.Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate\xe2\x80\x99s relevant skills, experience, and education.Expected salary range: $68,400.00 - $107,700.00Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed .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: NoTravel Requirements: 10%Flexible Work Arrangements: Not ApplicableShift: Not IndicatedValid Driving License: NoHazardous Material(s): n/aJob Posting End Date: 08/14/2024*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

MSD