Associate Specialist, Engineering (Onsite) jobs in United States
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Merck · 1 day ago

Associate Specialist, Engineering (Onsite)

Merck is a leading pharmaceutical company focused on delivering innovative healthcare solutions. The Associate Specialist role in the Technical Operations – New Production Introduction (NPI) team will contribute to the expansion of the FLEx Sterile facility, ensuring operational readiness and supporting formulation and process development activities.

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 the 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 our 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 ComplianceChemical Engineering FundamentalsProcess OptimizationQuality ManagementManufacturing Scale-UpStandard Operating Procedures (SOP)Aseptic ProcessingDesire to LearnCommunicationProblem-SolvingOrganizational SkillsAdaptability

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