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Merck · 8 hours ago

Senior Specialist, Engineering (Onsite)

Rahway, NJ

Full-time

Onsite

Senior Level

$117K/yr - $184K/yr

5+ years exp

Merck is a leading global healthcare company, and they are seeking a Senior Specialist in Engineering for their new FLEx Center in Rahway, New Jersey. This role will be responsible for leading sterile process engineering efforts, supporting complex formulations, and ensuring compliance with GMP standards during the startup and operation of the facility.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

No H1B

Responsibilities

Leverage leadership, technical, and communication skills to drive the success of the clinical manufacturing facility and organization

Lead and contribute to the launch and regulatory certification of the facility startup

Support the pipeline’s most technically complex formulations and process development through process tech transfer, scale-up activities, quality investigations, change management, technical operations support, and authoring GMP standard operating procedures and protocols in support of sterile clinical drug product operations

Collaborate closely with formulation scientists, engineers, operations staff, 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

Qualification

Chemical EngineeringGMP ComplianceProcess SimulationQuality InvestigationsStandard Operating ProceduresAseptic ProcessingLeadershipCommunication SkillsProblem-SolvingOrganizational Skills

Required

Bachelor's degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 5 years relevant experience

Master's degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 3 years of relevant experience, or a

PhD degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field

Excellent enterprise leadership skills demonstration

Excellent interpersonal and communication skills, both verbal and written

Experience in leading quality investigations and change management

Familiarity with United States and European Union GMP and Safety compliance regulations

Ability to convert new drug product attributes and process needs to an executable series of steps and procedures to enable acceptable product manufacture

Ability to prepare Standard Operating Procedures (SOP) and current GXP documents

Experience with quality systems

Excellent organizational skills

Desire and willingness to learn, contribute and lead

Track-record of independent problem-solving