Associate Director - Engineering Validation Technical Services in Somerville

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Job DescriptionJob Description

Position Brand Description:

This Validation Technical Services Leader will manage and lead the Validation Technical Services (VTS) group within the Engineering Organization supporting manufacturing operations for the monoclonal antibody production. This position is responsible for ensuring that all manufacturing equipment/systems are qualified/validated and are maintained in a validated state. This includes all activities associated with process and utility equipment qualification, including related automation qualification, Steam in Place and autoclave Performance Qualification (SIP PQ), revalidation for the biopharmaceutical manufacturing facility. This position ensures qualification meets internal and external compliance requirements and interacts with regulatory agencies during inspections and audits. This position is responsible for supporting the Process Teams in accordance with Manufacturing Standard for Operational Excellence (MSOE) 602 and representing Validation on the Flow Teams and Engineering Lead Team, as applicable.

Key Objectives/Deliverables:

Manage for Results /Strategic Planning:

1. Ensure objectives align to current and mid-term company priorities, including organizational, customer business unit and third-party goals.
2. 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.
3. Drive strategy and continuous improvements around procedures for C&Q and validation.
4. Evaluate changes to the validated state of systems through change control procedures and participate in the planning and implementation of changes.
5. Subject matter expert (SME) for equipment/system qualification, Steam in Place (SIP) requirements, Chamber Qualifications, Kaye Validators, eLabs, Utilities PQ, clean room PQs, etc.
6. Ensure that assets are always maintained in qualified state through the life cycle. Own asset qualification monitoring (AQM) program.
7. Oversee the scheduling and performance of all qualification and revalidation activities to ensure completion in a timely manner, according to area procedures.
8. Identify and implement improvement programs or projects to increase compliance, efficiency, quality, and safety of work performance.
9. Oversee the resource requirements, as necessary, to ensure the timely completion of all projects. Obtain contract support, as required.
10. Maintain cross-functional relationships with other departments, including Manufacturing, Engineering, Bioanalytical Sciences (BAS), Facilities/Utilities, Quality Control (QC), Quality Assurance.
11. Continually review all SOPs. Implement revisions, as necessary, to improve both quality and overall efficiency of C&Q processes.
12. Provide technical evaluations of validation issues supporting discrepancy / deviation investigations and develop corrective action plans, as required.
13. Participate in both regulatory and business unit inspections for all areas supported.
14. Implement personnel cross training and rotational work opportunities to ensure homogeneous operation of personnel within the group.
15. Manage contract and non-contract personnel working on the Branchburg campus to ensure compliance with corporate policies and campus training requirements.
16. Measure and appraise team performance against job duties, objectives, and goals. Provide accurate and timely feedback. Recommend merit increases, promotions, hires, and terminations.
17. Serve as area expert in cross functional meetings. Champion company policies to area staff.
18. Contribute and adhere to safety, environmental, quality, and EEO/AA standards of the Corporation.
19. Escalate issues to appropriate management level when necessary, following the appropriate notification to management process.

Manage Relationships with Key Stakeholders and Customers:

1. Drive cross functional alignment and integration of Validation within the Process Teams, Flow Teams and Engineering Lead Team.
2. Be the liaison between the Validation team and Production.

Staff Development and Management:

1. Measure and appraise staff performance against job duties, objectives, and goals. Provide accurate and timely feedback. Recommend merit increases, promotions, hires, and terminations.
2. Ensure staff are trained following standard operating procedures and cGMP guidelines.
3. Ensure development plans for staff are in place and active.
4. Appropriately managing medical cases following Employee Health Services recommendations.
5. Mentor/coach staff as well as lead staff with a high level of honesty and integrity.

Resource Management:

1. Fosters an inclusive workplace and engaged workforce.
2. Ensures effective hiring and staffing (right person for the right role).

Basic Requirements:

1. Bachelor of Science (or equivalent work experience) in Engineering discipline required.

2. Minimum 5 years of experience in a regulated (Pharmaceutical, Biopharmaceutical, Nuclear, etc.) Manufacturing organization.
3. Experience with Utilities and/or Manufacturing equipment in a Regulated industry.
4. Understanding of FDA and EU regulations and guidelines for C&Q.
5. Must be able to effectively oversee multiple complex activities (qualification, revalidation, change control activities) while directing team members, as applicable.
6. Must be able to effectively (clearly and accurately) communicate decisions to staff and upper management.
7. Must be able to mentor/ coach staff and lead staff with a high level of honesty and integrity.
8. Must be able to apply technical and operational experience to solve complex problems.
9. Must be able to write effectively as demonstrated through authorship of standard operating procedures, and technical reports.
10. Must have outstanding organizational and time management skills that will allow for effective prioritization of activities.
11. Must exhibit a team first attitude.
12. Must possess excellent communication, interpersonal, and written skills.
13. Must meet the physical requirements of the job; must have the ability to wear appropriate clean room attire.

Additional Preferences:

1. Experience in relevant area with supervisory experience in engineering and manufacturing operation environment.
2. Experience with ASTM E2500.
3. Knowledge of industry standards and regulatory requirements for C&Q within a cGMP regulated Facility.

The anticipated salary for this role is $135,000 - 180,000.

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 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 , , color, , , sexual , or expression, , protected veteran status, , or any other legally protected status.

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