Specialist, Process Engineer - Oral Solid Dosage, Clinical Manufacturing

at  Merck Sharp Dohme

JOB DESCRIPTION

The Formulation, Laboratory, and Experimentation (FLEx) Center is a multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical supply manufacturing facility in Rahway, New Jersey.
The Process Engineer role at the Specialist level will serve as a leader in the FLEx Oral Solid Dosage GMP Clinical Manufacturing facility. This role will support formulation and process development, scale-up activities, quality investigations, change management and authoring GMP standard operating procedures and protocols in support of oral solid dosage clinical drug product operations. This individual will 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. The role is based in New Jersey and reports to the Oral Solid Dosage Process Lead of the FLEx GMP facility within Pharmaceutical Operations and Clinical Supply.

EDUCATION MINIMUM REQUIREMENTS:

• Bachelor’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 1 year relevant experience
• Master’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field

REQUIRED EXPERIENCE AND SKILLS:

• 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 EXPERIENCE AND SKILLS:

• Experience or interest in supporting electronic batch records and MES systems.
• Ability to convert new drug product attributes and process needs to an executable series of steps and procedures to enable acceptable product manufacture.
• Experience in leading and supporting quality investigations and change management.
• Experience with Oral Solid Dosage GMP facility.
• Experience with Commissioning, Qualification and Validation.

TRAVEL REQUIREMENTS:

10%

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Current Contingent Workers apply HERE