Bachelor's degree in Engineering, Science, or a related technical discipline.
10+ years of relevant experience in engineering, technical operations, or related functions within the life sciences industry.
Significant experience in regulated environments like pharmaceuticals or biotechnology.
Strong technical writing skills for developing playbooks and structured documentation.
Proven ability to manage technical documentation repositories and knowledge-management systems.
Demonstrated experience in a senior technical or project leadership role.
Strong organizational skills with the ability to manage multiple priorities.
Responsibilities
Provide senior-level technical leadership across multiple program activities.
Develop and maintain technical playbooks, procedures, and standards.
Translate technical requirements into practical processes.
Create and manage a centralized technical repository for documentation.
Establish governance practices for document organization and version control.
Develop integrated schedules and coordinate deliverables across workstreams.
Facilitate technical sessions and track actions to completion.
Benefits
Opportunity to work in a dynamic, regulated life sciences environment.
Engagement with cross-functional teams and stakeholders.
Hands-on role with significant impact on program execution.
Chance to develop and standardize processes that enhance operational efficiency.
Full Job Description
We are seeking a highly experienced Senior Technical Lead - Program Standards & Knowledge Management to support a 12 month contract with a client in Raritan, NJ. The Senior Technical Lead will provide technical leadership, structure, and coordination for a complex program within a regulated life sciences environment. This individual will be responsible for developing and standardizing technical playbooks, establishing and maintaining a structured knowledge repository, coordinating program schedules and deliverables, and ensuring consistent execution across multiple stakeholders and workstreams. The ideal candidate combines strong technical expertise with excellent organizational and leadership capabilities. This is a hands-on role requiring someone who can independently develop frameworks, organize technical information, establish processes, and drive execution-not simply coordinate activities.
Description:
Provide senior-level technical leadership and coordination across multiple program activities and stakeholders.
Develop, write, and maintain technical playbooks, procedures, standards, templates, and execution frameworks.
Translate technical requirements, lessons learned, and best practices into clear, practical, and repeatable processes.
Create and manage a centralized technical repository that provides a structured and sustainable approach to documentation, standards, templates, decisions, and lessons learned.
Establish document organization, naming conventions, version control, ownership, and governance practices for the repository.
Develop and coordinate integrated schedules, milestones, priorities, dependencies, and deliverables across multiple workstreams.
Identify potential scheduling conflicts, technical gaps, dependencies, and execution risks and proactively drive resolution.
Facilitate technical working sessions and coordination meetings with cross-functional stakeholders.
Track technical actions and deliverables through completion and provide clear visibility of status, risks, and priorities.
Promote consistency and standardization across teams and projects.
Capture lessons learned and incorporate them into future playbooks, standards, and execution strategies.
Serve as a technical point of contact capable of communicating effectively with engineering, quality, operations, project management, and leadership.
Support continuous improvement of program processes, documentation, and execution methodologies.
Qualifications:
Bachelor's degree in Engineering, Science, or a related technical discipline.
Significant experience supporting pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments.
Demonstrated experience in a senior technical, engineering, program, or project leadership role.
Strong technical writing skills with demonstrated ability to develop playbooks, procedures, technical standards, guidelines, and structured documentation.
Experience establishing or managing technical documentation repositories and knowledge-management systems.
Strong understanding of project/program scheduling, milestones, dependencies, and cross-functional coordination.
Ability to organize complex technical information and convert it into practical, scalable processes.
Demonstrated ability to work independently, establish structure in evolving environments, and drive activities to completion.
Strong leadership, facilitation, communication, and stakeholder-management skills.
Highly organized, detail-oriented, and capable of managing multiple priorities simultaneously.
Strong proficiency with Microsoft Office and collaborative/document-management platforms such as SharePoint, Teams, or equivalent systems.
10+ years of relevant experience in engineering, technical operations, validation, manufacturing, quality, or related functions within the life sciences industry.
Experience supporting large capital programs, engineering portfolios, technology transfers, manufacturing programs, or other complex technical initiatives.
