Job Description

Technical Source is supporting a leading biopharmaceutical client in Raritan, NJ in the search for an Operations Readiness Project Engineer This role will sit onsite within the client’s engineering/CQV team and support multiple biologics and cell therapy projects through late-stage commissioning, qualification, validation (CQV), and operational startup.

You will be a key link between Engineering, CQV, Manufacturing, Quality, and Facilities—ensuring that systems, equipment, procedures, and people are fully prepared for compliant, on-time operations

Key Responsibilities

• Support operations readiness planning and execution across commissioning, qualification, validation, manufacturing, and quality functions for multiple projects.
• Coordinate readiness activities across Engineering, CQV, Manufacturing, Quality, and Facilities to ensure seamless handover into routine operations.
• Contribute to and help maintain integrated project schedules, including CQV milestones, interdependencies, and resource constraints.
• Identify, track, and help mitigate project and operational readiness risks, supporting contingency and recovery planning when needed.
• Coordinate and oversee aspects of CQV readiness, ensuring systems and equipment are prepared to meet regulatory and operational requirements.
• Support management of scope changes and assess readiness impacts to maintain original project and startup objectives.
• Develop or support cost estimates and forecasts related to readiness activities (labor, vendor support, and supporting services).
• Prepare and deliver project status reports, dashboards, and presentations for project stakeholders.
• Act as a day-to-day interface between cross-functional teams, helping drive decisions and alignment in a cGMP environment.
• Facilitate or support readiness reviews, risk workshops, and cross-functional meetings focused on startup and operational handover.
• Adhere to client governance, documentation, and reporting standards in a highly regulated environment.

Required Qualifications

• Education: Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline (or equivalent experience).
• Experience: 3–7 years of project engineering, project management, CQV, or operations readiness experience in pharmaceutical or biopharmaceutical manufacturing environments.
• Proven experience supporting operations readiness, startup, or late-stage project delivery, ideally across multiple workstreams.
• Strong understanding of the commissioning, qualification, and validation (CQV) lifecycle and how it integrates with manufacturing and operational readiness.
• Solid knowledge of cGMP requirements, engineering lifecycles, and pharmaceutical quality systems
• Demonstrated ability to work cross-functionally with engineering, manufacturing, quality, and facilities/maintenance teams.
• Experience coordinating vendors, contractors, and internal stakeholders to deliver scope on time and within budget.
• Strong communication, stakeholder management, and decision-making skills.
• Experience facilitating or actively participating in meetings and driving alignment in regulated environments.

Preferred Qualifications

• Experience in biologics and/or cell therapy manufacturing environments (upstream, downstream, or aseptic operations).
• Previous involvement in facility or line startup projects, tech transfer, or late-stage capex projects.
• Familiarity with ISPE Good Practice Guides and structured project management methodologies.
• Hands-on experience with project scheduling and reporting tools (e.g., MS Project, Primavera, Smartsheet, Power BI, or similar).
• Experience in a consulting or embedded role within a large pharma/biotech organization.

Soft Skills & Attributes

• Strong organizational skills and attention to detail, able to manage multiple projects and priorities in parallel.
• Proactive, resourceful, and comfortable working in a dynamic, fast-paced environment.
• Able to influence without formal authority and build strong working relationships with diverse teams.
• Comfortable working 100% onsite in a highly regulated manufacturing setting.