Pharma Validation Engineer & Scientist - Tech Ops

ADP, Inc.; Branchburg Township (NJ); On-site; USD 72,000 - 116,000; Full time

Benefits offered by this job

Paid time off

Medical insurance

Dental insurance

Vision insurance

Life insurance

Retirement plan

Wellness programs

Disability benefits

Job summary

Celltrion Branchburg, LLC in Branchburg, NJ is seeking an Engineer/Scientist-Technical Operations Validation to lead development and execution of installation, operational, and performance qualification protocols and reports to ensure compliant validation activities.

Based in the Contamination Control team, this role requires strong cGMP knowledge, excellent technical writing, problem solving, and the ability to coordinate with multiple departments to deliver on time.

Qualifications

• Strong communication skills, both written and verbal in a GMP environment.
• Understanding of data integrity principles (ALCOA+) and testing strategies.
• Ability to manage multiple validation activities and projects.
• Experience in biopharmaceutical validation lifecycle and regulatory requirements.

Responsibilities

• Develops and executes qualification and validation documents, including protocols and reports.
• Reviews protocols and technical reports and coordinates with internal teams.
• Performs cleaning validation/verification sampling and small-scale studies.
• Manages validation activities to ensure on-time delivery and compliance.
• Participates in design reviews to ensure user requirements are met.

Skills

Communication skills

Analytical thinking

Data integrity (ALCOA+)

Team collaboration

Problem solving

Education

Bachelor's degree in engineering or science

Tools

TrackWise

KNEAT

LIMS

Job description

Celltrion Branchburg, LLC in Branchburg, NJ is seeking an Engineer/Scientist-Technical Operations Validation to lead development and execution of installation, operational, and performance qualification protocols and reports to ensure compliant validation activities.

Based in the Contamination Control team, this role requires strong cGMP knowledge, excellent technical writing, problem solving, and the ability to coordinate with multiple departments to deliver on time.