Validation Engineer - Project Manager

Job Location

Summit, NJ

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Job Type

Workspace

Lead

On-site

Target Hiring Date

February 2025

Work Authorization

Applicants must have the legal right to work in the United States without requiring sponsorship. Corp-to-Corp (C2C) arrangements are not accepted.

Requirements

Education:

• Bachelor’s degree required in Science or Engineering.

• 5+ years relevant work experience required, preferably in a regulated pharmaceutical manufacturing environment.

• PMP certification strongly preferred.

• Experience in biopharmaceutical clinical, supply chain, manufacturing, and commercialization.

  Qualifications:

• Ability to work independently.

• Ability to matrix manage cross functional teams.

• Must be competent in Project Management tools and methodologies.

• Excellent organizational and time management skills.

• Experience with regulated GMP environment for manufacturing (Biologics or Cell Therapy experience is a plus).

• Strong analytical, problem-solving, and critical thinking skills.

• High attention to detail skills.

• High organization skills with ability to multi-task several objectives in parallel.

• People and project management skills.

• Advanced proficiency in MS Office applications.

• Proficient written and verbal communication skills.

• Ability to develop and provide training on various functions

  Physical Requirements:

• This role may involve working in an office, laboratory, or manufacturing area.

• Must be able to work in gowning attire within a controlled environment for extended periods.

• Must demonstrate the ability to work safely with hazardous, radioactive, and biological materials and waste, ensuring safety both when working independently and with others.

• Must be able to lift up to 15 pounds as needed.

About the Role

The Project Manager will develop project plans, develop, and manage timelines, identify, and respond to critical path barriers. The role will require significant collaboration across internal and external functions to ensure on-time release of the final product. An Ideal candidate will have demonstrated ability to balance multiple competing priorities, manage projects. The role is required to work in a cross-functional and dynamic setting where project assumptions and scenarios may change and therefore requires an individual who can quickly adapt to the changes and manage communications at different levels in the organization.

Work scope will include operations excellence, continuous improvement projects and capacity expansion projects in support of commercial products. This role will work with project management and subject matter experts across multiple sites including Manufacturing, Operational Excellence, Supply Chain, MS&T, Quality Assurance, Quality Control, Process Development, CMC, TT lead, TCT lead, Global Engineering, Facilities Engineering, PMO, IT, EHS, Finance, Regulatory, and Clinical and Commercial Operations.

DUTIES AND RESPONSIBILITIES:

• Manage multiple, low to medium complexity process improvement and/or technical projects and timelines.

• Effectively manage team meetings, including the scheduling of meetings, the preparation of agendas, the development of meeting minutes, and the follow-up on action items.

• Serve as a member of sub-teams, tracking timelines elements to ensure that functional deliverables are completed on time and according to relevant quality standards

• Develop critical path analyses with the team to understand risks and opportunities within project timelines and help develop contingency plans

• Responsible for the preparation of routine status reports and communicate project progress to stakeholders

• Lead operational projects including weekly QC LIMS huddles, QC CTDO LIMS planning and management and monitoring tools

• Ensure that team recommendations related to project direction and timelines which need endorsement by governance teams are planned for review at appropriate milestones

• Promote a culture of collaboration, cooperation, execution excellence, effective communication, and cross-functional problem-solving to enable a high-performing team.

• Develop and implement KPI and reporting capabilities

• Collaborate with IT Business Partners in support of modeling, scheduling simulation implementations and automated scheduling tools.

About the Company

Join Sokol GxP Services – Where Innovation Meets Integrity!

Join Sokol GxP Services, where we partner with leading pharmaceutical and biotech companies to provide exceptional Commissioning, Qualification, and Validation (CQV) services. We are committed to fostering diversity, empowering local talent, and building strong community connections to bring the best-qualified candidates to our clients in the Summit, NJ area. Our inclusive and collaborative culture promotes growth and innovation, offering competitive health benefits, PTO, holiday pay, volunteer hours, a relocation budget, a 401K* program, and professional development opportunities. Plus, take advantage of our Employee Referral program! Be part of a dynamic team with fantastic opportunities for growth and professional development!

Let’s shape the future of life sciences together!

All applicants will receive an acknowledgement that their application has been received within 2-3 weeks from the from the date of receipt.

Equal Opportunity Employer Statement:

Sokol GxP Services is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

*Relocation support will be determined on a case-by-case basis.

**Our 401K program is set to launch in the 2025 fiscal year.

By submitting your application and resume, you consent to have your information retained in our repository for six months. This allows us to consider you for future opportunities that may align more closely with your skills and qualifications. If a suitable position becomes available, we will contact you directly.

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