Engineer/Scientist-Technical Operations Validation

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

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Engineer/Scientist-Technical Operations Validation

Full Time Branchburg, NJ, US

2 days ago Requisition ID: 1134

Salary Range: $72,000.00 To $116,000.00 Annually

Position Brand Description:

This position requires knowledge of cGMPs, excellent technical writing, and problem-solving skills. Responsibilities will include but not limited to development and execution of installation, operational, and performance qualification protocols and reports, ensuring qualification and validation activities meet internal and external compliance requirements, effectively manage projects to deliver on time and consistent results, and coordinating validation activities with the appropriate functional groups. This position is part of the Contamination Control team.

Manage for Results /Strategic Planning:

• Develops and executes qualification and validation documents, including protocols and reports, product stage determination documents and cleaning execution plans.
• Reviews protocols and technical reports, both within and external to Technical Operations.
• Performs cleaning validation/verification sampling, small-scale studies, and submits samples for analysis.
• Performs hold studies to support qualified manufacturing hold time for process buffers.
• Schedule and coordinate cleaning and changeover activities with Manufacturing areas.
• Maintains the validated state of process equipment through cleaning monitoring and trending of cleaning cycles.
• Participates/facilitates in design reviews to ensure design meets user requirements.
• Develops and/or updates validation SOPs and Policies,
• Prioritizes validation activities. Communicates and documents status to management and appropriate departments.
• Uses effective project management skills to manage multiple activities and ensure on-time project delivery.
• Provides technical evaluations of complex validation issues supporting discrepancy / deviation investigations and develops corrective action plans, as required.
• Evaluates changes to the validated state of systems through change control procedures and participates in the planning and implementation of changes.

Manage Relationships with Key Stakeholders and Customers:

1. Participate in Process Flow Teams as needed.

Basic Requirements:

• Position is a banded position; education and years of experience in a cGMP biopharmaceutical or pharmaceutical manufacturing and/or development environment will be considered for initial placement within the band.
• Ability to work with others in a fast-paced environment.
• Strong communication skills, both oral and written to effectively communicate technical information in a clear and concise manner within a GMP environment.
• Strong analytical, problem solving, and excellent interpersonal skills.
• Understanding of key Data Integrity principles (ALCOA+) to ensure requirements are aligned to appropriate testing strategies.

Additional Preferences:

• Knowledge of validation lifecycle approach and FDA/international regulatory requirements.
• Knowledge of contamination control strategies.
• Experience with the following applications/systems is a plus: TrackWise, KNEAT, LIMS.

Education Requirements:

1. Bachelor’s degree in engineering, Science, or related discipline.

Other Information:

1. Travel not required.

2. Lifting required (NMT 50 lbs.)

3. Occasional off hours work to accommodate manufacturing schedule.

4. On a non-routine basis, confined space entry and tank entry with the use of a harness may be required.

This role is exempt and the anticipated compensation for this role is $72,000 - $116,000.

This is a banded role, and candidates will be placed within the range based on experience, skills, internal equity, and market considerations.

Celltrion Branchburg, LLC offers a comprehensive benefits package that includes paid time off (holidays, vacation, and additional leave), medical, dental, and vision insurance, life insurance, a company-matched retirement savings plan, wellness programs, and short- and long-term disability benefits. This role requires up to 10% travel, on-call availability, and may involve shift work. Hybrid work flexibility may be available based on business needs; relocation assistance is not provided.

Celltrion Branchburg, LLC is proud to be Equal Opportunity Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity or expression, national origin, protected veteran status, disability, or any other legally protected status.