Engineering Specialist - Commissioning, Qualification, and Validation (CQV)

Merck • Rahway, NJ

13d • Hybrid

About The Position

The Engineering Specialist is a key role within Our Company’s Research Labs Pharmaceutical Sciences – Pharmaceutical Operations Engineering group (Pharm Ops Engineering), responsible for Commissioning, Qualification, and Validation (CQV) and broader engineering support across non-sterile operations, including formulation, filling, and packaging of Oral Solid Dosage and Inhalation products.
The position leads CQV development and execution for new and modified processing equipment, systems, and critical utilities. Author and execute protocols aligned with cGMP and develop Validation Master Plans, Project Execution Plans, and schedules to support capital projects.
Primary responsibility will be to provide ongoing commissioning/qualification/validation related to changes and new equipment purchases within our Research & Development division's Clinical Supply for both GMP and development use. This role partners with site business areas, equipment manufacturers, vendor representatives, and local suppliers, acting as a CQV subject matter expert during Quality Risk Assessments and applying Good Engineering Practice to Computerized Calibration Management Systems (CCMS) and Computerized Maintenance Management Systems (CMMS) configuration (e.g., instrumentation parameters and maintenance activities).
Responsibilities include coaching personnel in Good Documentation Practice and timely completion of required documentation; performing risk-based methodologies to assess GMP criticality; assisting with accuracy of As-Built drawings; and supporting Root Cause Analysis, CAPA development, FMEA, and PHAs for deviations encountered during CQV.
Candidates should hold a bachelor’s degree in engineering or science with at least two years of qualification/validation experience, and demonstrate strong knowledge of commissioning, qualification/validation (including periodic review), familiarity with Quality and cGMP policies and procedures, and experience with CMMS/CCMS systems. Effective organizational and communication skills, strong computer proficiency, and the ability to flexibly support both Quality and Facilities work are essential, with preferred experience in Kneat (paperless validation), computerized maintenance and calibration management systems, and the capability to work independently while leading or facilitating tasks.
The role is based in Rahway, NJ, and may include travel to West Point, PA as needed. We seek individuals who demonstrate strong ownership and accountability, proactively drive sound decisions, and demonstrate responsibility. Joining this team offers meaningful opportunities for Talent Growth and to make a sustained impact on product reliability and patient safety to continue advancing our mission.

Requirements

• Experience with current Good Manufacturing Practices (GMP) and Good Documentation Practices (GDocP)
• Experience in GMP pharmaceutical manufacturing plant operations
• Knowledge of commissioning and qualification/validation processes, including periodic review
• Familiarity with Quality, cGMP, Safety, and Environmental policies and procedures
• Familiarity with CMMS and CCMS
• Ability to flexibly adapt and prioritize work across both Quality and Facility-related activities to support business needs
• Strong organizational skills with the ability to manage multiple tasks and priorities
• Effective verbal and written communication skills
• Strong computer literacy, including the use of standard business software applications

Nice To Haves

• Experience with Kneat or similar paperless electronic validation systems
• Experience with SAP Plant Maintenance
• Demonstrated ability to work independently and to lead or facilitate tasks and small projects successfully
• Working knowledge of regulatory requirements relevant to CQV for GMP manufacturing facilities and equipment
• Experience with one or more of the following: oral solid dosage (OSD), tablet compression, encapsulation, spray drying, film coating, dry powder inhalers, drug product-device assembly lines, isolators, and/or containment technologies
• Experience working with Lean, Six Sigma, and/or continuous improvement initiatives including Failure Mode and Effects Analysis (FMEAs), Process Hazard Analysis (PHAs)
• Familiarity with OSD process equipment operations

Responsibilities

• Develop, execute, and maintain Commissioning, Qualification, and Validation (CQV) documentation
• Participate in and support continuous improvement activities within the oral solid dosage facility
• Ensure adherence to Good Manufacturing Practices and demonstrate compliance with the Quality Manual, Standard Operating Procedures (SOP), and applicable guidelines
• Support investigations and contribute to the development and implementation of corrective and preventive actions (CAPA)
• Support external and internal audits, tours, and regulatory inspections
• Complete required training in a timely manner and maintain training records in a current state

Benefits

• The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
• We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees