Associate Specialist, Engineering (Onsite) jobs in United States
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Merck · 15 hours ago

Associate Specialist, Engineering (Onsite)

Merck is a leading global healthcare company, and they are seeking an Associate Specialist in Engineering to contribute to the FLEx Sterile Expansion project. This role involves supporting technical transfer, manufacturing science, and operational readiness activities to ensure the quality of clinical supplies and the success of the expansion project.

BiotechnologyHealth CareMedicalPharmaceutical
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Comp. & Benefits
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Responsibilities

Make significant contributions in technical transfer, manufacturing science and technology, startup and operational readiness activities and deliverables related to the expansion project
Collaborate closely with formulation scientists, engineers, quality representatives, and other team members to ensure the quality of the clinical supplies, the scientific rigor of the processes, and ultimately to enable the flexibility and speed of the Company's pipeline
Support the formulation, process development, and scale-up activities, quality investigations and change management, standard operating procedures and protocols in support of sterile clinical drug product operations

Qualification

GMP ComplianceStandard Operating ProceduresDrug Product Aseptic ProcessingCommissioningQualificationPharmaceutical Quality AssuranceChemical EngineeringQuality InvestigationsDesire to LearnEffective CommunicationOrganizational SkillsProblem-SolvingAdaptability

Required

+ Bachelor's degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field by May 2026
+ Familiarity with United States and European Union GMP and Safety compliance regulations
+ Ability to prepare Standard Operating Procedures (SOP) and current GXP documents
+ 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

Preferred

+ Ability to convert new drug product attributes and process needs to an executable series of steps and procedures to enable acceptable product manufacture
+ Knowledge of drug product aseptic processing, equipment and sterile technique
+ Experience in leading and supporting quality investigations and change management
+ Experience with sterile GMP facility startup
+ Experience with Commissioning, Qualification and Validation
+ Knowledge of Investigational drug regulatory requirements
+ Understanding of Clinical Supply Chain Operations

Benefits

Medical, dental, vision healthcare and other insurance benefits (for employee and family)
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate and sick days

Company

Merck is a biopharmaceutical company that offers medicines and vaccines for various diseases.

Funding

Current Stage
Public Company
Total Funding
$5.59M
Key Investors
Private Capital AdvisorsGavi, the Vaccine Alliance
2018-11-25Post Ipo Equity· $0.59M
2016-01-21Series Unknown· $5M
1980-12-19IPO

Leadership Team

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Betty Larson
Executive Vice President and Chief Human Resources Officer
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Dean Li
Executive Vice President and President, Merck Research Laboratories
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Company data provided by crunchbase