Project Manager

Alliance Group Technologies Inc; Branchburg Township (NJ); On-site; USD 120,000 - 180,000; Full time

Job summary

Alliance Group Technologies Inc in New Jersey is seeking an experienced engineering Project Manager to independently lead and deliver multi-million-dollar capital projects in the pharmaceutical/biotech sector, under the direction of the capital project lead. This role requires strong knowledge of cGMP, regulatory expectations, and cross-functional teamwork.

You will develop master schedules, refine scopes with stakeholders, prepare cost estimates and capital requests, issue RFPs, manage project

Qualifications

• Bachelor's degree required in a relevant field.
• Minimum 5+ years managing capital projects.
• Experience in pharma/biotech facility projects.
• Knowledge of cGMP, FDA/EMA guidelines.
• Excellent written and verbal communication.
• Proficient with project controls and forecasting.

Responsibilities

• Lead and manage multiple engineering and construction projects in the multi-million-dollar range under the capital project lead.
• Develop master schedules for system delivery to end user, including commissioning and qualification.
• Refine scope and user requirements with stakeholders for third-party detailed design.
• Develop and refine project cost estimates and capital requests (eCIR).
• Prepare RFPs and bid packages for engineering design, equipment, and construction.
• Manage project financials: capital approval, POs, invoicing, capitalization.
• Hold progress review meetings and resolve issues to meet scope, budget, and schedule.
• Prepare and manage change controls for associated projects.
• Track engineering, project, and GMP documentation to closure.

Skills

Leadership

Project management

Regulatory knowledge

Stakeholder communication

cGMP

Lean/Six Sigma knowledge

Budgeting/Cost control

Vendor coordination

Education

Bachelor’s Degree in Engineering, Architecture, Construction Management, or Engineering Technology

Tools

MS Project

Primavera

CMMS

PLC/HMI systems

OSI PI

Job description

• Independently lead, facilitate and manage the execution and the delivery of multiple engineering and construction projects in the multi-million-dollar range under direction of the capital project lead. Projects to include systems considered both cGMP qualified and non-qualified as regulated by applicable regulatory agencies.
• Assist in master schedule development for all aspects of projects through system delivery to end user including system commissioning and qualification, as necessary.
• Develop and refine scope and user requirements with stakeholders that will be used as the basis for detailed design developed by a third-party engineering design firm.
• Develop and refine project cost estimates.
• Prepare and submit capital requests (eCIR) to obtain funding for individual projects.
• Prepare Requests for Proposal (RFPs) and bid packages for engineering design, equipment, and construction activities.
• Manage project financials including obtaining capital approval, PO issuance, invoicing, and project capitalization.
• Hold meetings to review progress and resolve issues, as necessary, to ensure that project scope, budget and schedules are maintained.
• Preparation and management of change controls for associated projects.
• Track required engineering (specifications, drawings, maintenance, etc.), project (RFIs, shop drawings, etc.) and GMP (change management, protocols, reports, procedures, etc.) documentation to closure

Qualifications:

• Minimum 5 plus years of experience in engineering, design, construction, maintenance, and/or commissioning/qualification/validation, including management of facility-type projects in the pharmaceutical/biotechnology industry.
• Ability to manage several projects simultaneously.
• Knowledge of cGMP regulations and practices (C&Q, SIP, EM, CSV, change controls, FDA and EU guidelines, current industry trends).
• Strong written and verbal communication skills.
• Proficiency in Microsoft Project, including knowledge of resource loading and critical path.
• Experience in forecast spend and project controls
• Experience and working knowledge of construction site safety practices and procedures.
• Ability to work independently with minimum supervision.
• Ability to lead and work as part of a team to execute multi-disciplined projects.
• Knowledge of computer systems (CMMS, PLC, HMI, OSI PI) and process equipment or utility systems.
• Strong organizational, analytical, and problem-solving skills; ability to build relationships, lead teams, and influence without authority.
• Bachelor’s Degree in Engineering, Architecture, Construction Management, or Engineering Technology.
• Proven leadership of capital projects >$5M.
• Strong knowledge of GMP, FDA/EMA regulations, and validation principles.
• Experience with facility design, process equipment, utilities, and construction management.
• Proficiency with project management tools (MS Project, Primavera, or equivalent).
• Excellent communication and stakeholder management skills.
• PMP certification preferred.
• Experience in Lean Manufacturing, Six Sigma, or other productivity methods preferred.