Job Description

JOB PURPOSE

The PTO Associate Director Engineering/ Chemistry (M2) ensures oversight,coaching of the technicalteam on their technical support activities related to the commercialization and the manufacture of alldrug products on site. These activities include (but are not limited to)product and cleaningvalidations, technologytransfer,audit/compliancesupport, process monitoring,product portfolio and new product introductionThe PTO Associate Director Engineering / Chemistry demonstrates advanced knowledge of the end-end supply chain and must work effectively within cross-functionalteams inestablishing priorities for the IPT and department.In addition, he/she provides technical guidance/directionfor the PTO engineers/ chemists with the technical knowledge/ compliance knowledge/ essential skills needed for their technical supply support activities.

The PTO Associate Director isexpected to build and develop his/her teamsHe/ She will have people management responsibilitiesand isaccountable forestablishing the priorities and providing oversight ofcareerdevelopmentplansfor their direct reports. Inaddition, he/sheleadsand providessubject matter expert (SME) technical guidance tothesiteandregionallyinprocess improvement activities,investigationsand contributes to global technical networks to share site and regional experiences. ThePTO Associate Director Engineering/ Chemistry also leads continuous process improvement or strategic initiatives activities toenhance site performance metrics and provides expert knowledge to the site and across the ourglobal companytechnicalnetwork (while leveraging on other siteexperiences/ knowledge)and continuouslyexpands on personal expertise.

WHAT YOU WILL DO

MAINRESPONSBILITIES(Prioritiestobealignedwithdirectsupervisor)

Coaches and mentors, thePTOEngineers /Chemistsontheir technical support activitiesrelated tocommercializationand manufacture of drug products on site. Key activities include but are not limited to:

• Newproductintroductions,technologytransfer activities

• Deviationsandcustomercomplaintsinvestigations

• Proactiveprocessanalysisandmonitoring

• Processand cleaning related activities (such asequipment qualification, validation, verifications,monitoring,CPV, APR activities)

• QMStopicsespeciallyforPTOownedtopics

• Audit/Compliancesupport

• Productportfolio

• Realtimeproblemsolving(RIPS)forshopfloor investigations

• Statisticalandproblem-solving tools

Isconversant and able tocoach inall technical support areas. Accountable forhis/herteams in therespective IPT areasby making results/issuesvisible,effectivelymanaging the execution of the activities and addressing issues systematically.

• Provides technical support for new product transfers to other sites,investigations to deviations and process improvement activities toimprove robustness as well astechnical training tobuild capabilities atsiteor regionally.Expectedto leverage onindustry practices toenhanceor transform current practices and processes,lead the implementationof newtechnology or practices to thesiteand regionallyExpected tobe theSME on specific technical knowledge related to processengineering, scale up, designing experiments, etc.

• Providesoversightandisexpectedtohaveatleastadvancedknowledgeon technicalsupplysupport.Expectedto possess advanced knowledge and islikelytobeaSME inspecific technical/processengineering knowledge related to relevant drug substance/drug product non-sterile or sterile manufacturing technologiesSupervises complex equipment/process/automationchanges asrequired for process improvements,including changes to process/cleaningbatch sheets.

• Expected tostay abreast of recentdevelopments in major regulatoryguidance issued by theFDA,EMAetc,and proactively assess impact and changes required for the current operations.

• Supportsroutine supply manufacture by providing ongoingtechnical supporttotheIPTduring manufacturing and cleaning and regulatory auditsExpected to positively influence site partners (IPT, Quality) on process improvements, remediation plans and the introduction of proactive monitoring for the various manufacturing processes. Expected to lead/supportthe identification and prioritization of opportunities for continuous process improvements based onfeedback from proactive monitoring in the plant, e.g through Proactive Process Analysis (PPA)

• In addition, provides ongoing technical support to the IPT, participates in Tier processes and recommends projects/opportunitiesfor improvement and implements opportunities for improvement utilizing MPS (our ProductionSystems)tools. Ensures optimumproduction runs,identifies constraints and non-conformancesand troubleshoots to resolve complex issues in production systems. In addition,conceptualizes process designs to troubleshootandresolvecomplexoperational ormanufacturingissuesand recommend enhancementsto improve productionrunsandenablecontinuousimprovementoftheproductcost structure

• Leadssignificant/complexinvestigations.

• Serves as technical approver fordeviation investigations,cleaning,process validations, risk assessments,change controls, CPV and other technical documents as applicable.

• Leadsand drivesstrategyandinitiativesalignedtositeandfunctionalHOSHIN.Leadsworkstreamsorinitiativesin driving benefits to transform the business, products, processes or unit operations with respect to technical excellence, robustness, risk mitigation and compliance.

• Collaborates withsitefunctional groupsindeliveryof sitetargets and shows commitment tocollaboration and sharing of best practices across the our global companyS&T network.

• Demonstrates and promotes Environmental,Health & Safety(EHS) leadership behaviors,ensuring that all activities are carried out in accordance with EHS requirements. Activelyparticipates in GEMBA safety walks. Leads/ participates inprocesshazards analyses (PHA)and applicableProcess Safety Management (PSM)activitiesrelated to new/commercial products.

• Where applicable,writesand reviewsSOPs, gap analysesand Job AidsforPTO QMS topics incompliance withdivisional and corporate policies and Qllidelines

• Demonstrates leadership behaviors in alignment with our leadership standards (Individual Contributor/Manager), specificallyonFostering Collaboration,Building Talent and Driving ResultsPractices Inclusion,Safe by Choice principles and possesses a strong our Production Systems (MPS) mindset. Leads personal career developmentwith manager assistance through annual Performance Management Process (PMP), Employee Development Plan (EDP) and career mappmg.

• Has primary oversight for thedevelopment of engineers/chemiststhrough administrationof theindividuals' priorities,EDP and career mapping.

ACCOUNTABILITIES

• Conductsallactivitiesincompliance withsiteanddivisional policies, guidelinesandproceduresandwithinthedefinedsafetyrequirements.

• Successfully completesendtoendtechnologytransfersintooroutofthesite through provision of oversight to technologytransfer team(s)

• Successfully executes changes to validated systems: process/ equipment/ automationandcleaningeitherdirectlyorthroughsupervision ofdirectreports and/or junior staff.

• Deliversonallassigneddepartment andcrossfunctional initiativeswithin the required time frame

• Resolvescomplexdeviations, investigationsandcustomercomplaintswith proper root cause analysis and CAPAs

• Leads workstreams or initiatives in driving benefits to transformthe business, products, processes or unit operations with respect to technicalexcellence, robustness, risk mitigation and compliance.

• Buildsknowledge andexperience toexpand responsibilitiesforthenextrolein PTO.

• Administersrobustandsustainablepeopledevelopmentplanfordirect reports.

WHAT YOU MUST HAVE

Qualification:

• Bachelors,master'sorPh.D. degree in a technical field,including Chemical or Mechanical Engineering,Chemistry or Pharmaceutical Sciences

Experience:

• Minimum 8 years technical experience in related pharmaceuticalmanufacturing industry

• Minimum 2 yearsinsupervisoryposition of professional staff ordemonstrated capability to successfullylead large teams in complex projects

• Expert knowledge of core technology/unitoperations relevant toactive pharmaceutical ingredient, Biotech and/or Non-Sterile manufacturing

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 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.

Required Skills:

Computerized Maintenance Management Systems (CMMS), Cross-Cultural Awareness, GMP Environments, Maintenance Supervision, Manufacturing Quality Control, People Leadership, Pharmaceutical Development, Process Engineering, Process Improvements, Regulatory Compliance, Regulatory Inspections, Single-Use Systems (SUS), Sterile Manufacturing, Strategic Thinking, Team Leadership

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

06/10/2026

*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.