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Merck · 19 hours ago

Associate Director, Engineering (Onsite)

Rahway, NJ

Full-time

Onsite

Lead/Staff, Director/Executive

$142K/yr - $224K/yr

5+ years exp

Merck is a leading pharmaceutical company that focuses on drug product development and manufacturing. The Associate Director, Engineering will lead the equipment engineering team, ensuring reliable production across aseptic formulation and sterile filling processes while collaborating with various departments to support operational goals.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

H1B Sponsored

Responsibilities

Monitor and improve manufacturing processes, including data and reports supporting regulatory compliance of drug products as they are processed through formulation and aseptic fill/finish

Define and direct staff activities to plan, execute, and document experiments, studies, and manufacturing processes that qualify key equipment, raw materials, and processes for clinical and commercial production

Build and maintain a high-performing staff of engineers to support ongoing production and process transfers

Serve as a key scientific and technical representative for process-related issues at internal sites and with external partners

Partner with Manufacturing to meet production schedules, ensure commercial supply, and uphold quality standards

Perform trending and monitoring of critical attributes to maintain equipment health and control process drift

Identify and implement process improvements in collaboration with manufacturing operations

Review and provide feedback on project deliverables and offer technical/scientific support (e.g., remediation initiatives, reports)

Lead investigations with Manufacturing, Quality, and other business units to determine root causes for variations, implement solutions, and ensure corrective actions are effective

Collaborate with other departments on manufacturing-related issues to resolve problems and support organizational goals

Own the process, plan to avoid delays, and lead activities to ensure a robust and effective product and manufacturing process

Perform other related duties as assigned

Qualification

Chemical EngineeringAseptic ProcessingGMP ComplianceLean Six SigmaQuality InvestigationsProcess ImprovementsRegulatory ComplianceLeadershipCommunication SkillsProblem-SolvingCross-Functional TeamworkOrganizational Skills

Required

Bachelor's degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 7 years relevant experience

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

PhD degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 2 years of relevant experience

Excellent interpersonal and communication skills, both verbal and written

Expertise in drug product aseptic processing, equipment, and sterile technique

Experience in leading quality investigations and change management

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

Lean Six Sigma Experience

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