Celltrion Inc · 21 hours ago
Associate Director - Engineering Validation Technical Services
Branchburg, NJ, US
Full-time
Hybrid
Lead/Staff, Director/Executive
$135K/yr - $180K/yr
5+ years expCelltrion Inc is a biopharmaceutical company focused on monoclonal antibody production. The Associate Director will lead the Validation Technical Services group, ensuring that all manufacturing equipment is qualified and compliant with internal and external regulations while overseeing qualification activities and cross-functional relationships.
HealthcarePharmaceuticalHealth Care
Responsibilities
Ensure objectives align to current and mid-term company priorities, including organizational, customer business unit and third-party goals
Develop and implement validation policies. Maintain validation master plans, and ensure all activities performed in support of policies and master plans are compliant to current regulations
Drive strategy and continuous improvements around procedures for C&Q and validation
Evaluate changes to the validated state of systems through change control procedures and participate in the planning and implementation of changes
Subject matter expert (SME) for equipment/system qualification, Steam in Place (SIP) requirements, Chamber Qualifications, Kaye Validators, eLabs, Utilities PQ, clean room PQs, etc
Ensure that assets are always maintained in qualified state through the life cycle. Own asset qualification monitoring (AQM) program
Oversee the scheduling and performance of all qualification and revalidation activities to ensure completion in a timely manner, according to area procedures
Identify and implement improvement programs or projects to increase compliance, efficiency, quality, and safety of work performance
Oversee the resource requirements, as necessary, to ensure the timely completion of all projects. Obtain contract support, as required
Maintain cross-functional relationships with other departments, including Manufacturing, Engineering, Bioanalytical Sciences (BAS), Facilities/Utilities, Quality Control (QC), Quality Assurance
Continually review all SOPs. Implement revisions, as necessary, to improve both quality and overall efficiency of C&Q processes
Provide technical evaluations of validation issues supporting discrepancy / deviation investigations and develop corrective action plans, as required
Participate in both regulatory and business unit inspections for all areas supported
Implement personnel cross training and rotational work opportunities to ensure homogeneous operation of personnel within the group
Manage contract and non-contract personnel working on the Branchburg campus to ensure compliance with corporate policies and campus training requirements
Measure and appraise team performance against job duties, objectives, and goals. Provide accurate and timely feedback. Recommend merit increases, promotions, hires, and terminations
Serve as area expert in cross functional meetings. Champion company policies to area staff
Contribute and adhere to safety, environmental, quality, and EEO/AA standards of the Corporation
Escalate issues to appropriate management level when necessary, following the appropriate notification to management process
Drive cross functional alignment and integration of Validation within the Process Teams, Flow Teams and Engineering Lead Team
Be the liaison between the Validation team and Production
Measure and appraise staff performance against job duties, objectives, and goals. Provide accurate and timely feedback. Recommend merit increases, promotions, hires, and terminations
Ensure staff are trained following standard operating procedures and cGMP guidelines
Ensure development plans for staff are in place and active
Appropriately managing medical cases following Employee Health Services recommendations
Mentor/coach staff as well as lead staff with a high level of honesty and integrity
Fosters an inclusive workplace and engaged workforce
Ensures effective hiring and staffing (right person for the right role)
Qualification
Required
Bachelor of Science (or equivalent work experience) in Engineering discipline required
Minimum 5 years of experience in a regulated (Pharmaceutical, Biopharmaceutical, Nuclear, etc.) Manufacturing organization
Experience with Utilities and/or Manufacturing equipment in a Regulated industry
Understanding of FDA and EU regulations and guidelines for C&Q
Must be able to effectively oversee multiple complex activities (qualification, revalidation, change control activities) while directing team members, as applicable
Must be able to effectively (clearly and accurately) communicate decisions to staff and upper management
Must be able to mentor/ coach staff and lead staff with a high level of honesty and integrity
Must be able to apply technical and operational experience to solve complex problems
Must be able to write effectively as demonstrated through authorship of standard operating procedures, and technical reports
Must have outstanding organizational and time management skills that will allow for effective prioritization of activities
Must exhibit a team first attitude
Must possess excellent communication, interpersonal, and written skills
Must meet the physical requirements of the job; must have the ability to wear appropriate clean room attire
Preferred
Experience in relevant area with supervisory experience in engineering and manufacturing operation environment
Experience with ASTM E2500
Knowledge of industry standards and regulatory requirements for C&Q within a cGMP regulated Facility
Benefits
Paid time off (holidays, vacation, and additional leave)
Medical, dental, and vision insurance
Life insurance
A company-matched retirement savings plan
Wellness programs
Short- and long-term disability benefits
Company
Celltrion Inc
Celltrion is a fully integrated biopharmaceutical company dedicated to delivering innovative and affordable medications to improve patients’ access to advanced therapies.
1001-5000 employees
H1B Sponsorship
Celltrion Inc has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2023 (1)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
unknown2023-08-17Acquired
2017-07-28IPO
Recent News
2025-12-31
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