Biopharmaceutical - SENIOR PROJECT MANAGER CQV - Holly Springs, United States - MMR Consulting

Description

Biopharmaceutical - SENIOR PROJECT MANAGER CQV

Previous Pharmaceutical/Biotech experience is mandatory for this role.

MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical, and biotechnology industries in the US & Canada. Its services include Engineering, Project Management, and other Consulting services. MMR's Engineering expertise includes Process, Automation, Facilities engineering. Pharmaceutical expertise includes Oral Solid Dosage, Semi-Solids, Liquid-Dosage (TS and Aseptic), API manufacturing, Biotechnology (Vaccines, Blood Plasma Fractions, Monoclonal Antibodies).

This is an outstanding opportunity to join our growing team, where the successful candidate will work with a group of engineers involved in the design, commissioning & qualification, start-up and project management of various processes, systems and facilities. The work may require working out of client's facilities, which are typically in the RTP, NC area.

Responsibilities

• Provide technical guidance into the engineering assessments, design, project management, commissioning and start-up of equipment and facilities, for upgrades, renovations and expansions of client facilities and processes.
• Lead or support project execution from feasibility through to project completion/handover, including all project stages such as:

Feasibility Assessments

Concept Design, Basic Design, Detailed Design

Procurement

Construction / Installation

Project Controls - Monitoring

Commissioning & Qualification

• Prepare business cases, with project purpose, risks, budget, schedule, resource requirements.
• Manage other engineering design firms, equipment vendors, construction firms and internal / external stakeholders as required to execute projects.
• Review technical documentation such as P&IDs, specifications, layouts, manuals, datasheets.
• Integrate safety into the design and execution of all projects (HAZOP reviews, PHSRs, design reviews with EHS representatives).
• Prepare/review automation sequences, as required for Process Automation.
• Engage and coordinate with other engineering disciplines and other cross-functional departments (Process, automation, building / facilities, procurement, construction management, commissioning, qualification & validation, manufacturing operations, EHS, quality & compliance).
• Facilitate project management tools throughout the execution of projects, such as procurement tracking, vendor management, meeting minutes / action lists, risk register log, schedule updates, project updates.
• Coordinate meetings with cross-functional departments, to drive project progress, facilitate decisions, provide updates.
• Travel may be occasionally required for meetings with equipment fabrication vendors or Factory Acceptance Testing (FATs).
• Work may require occasional support over shutdowns or extended hours, specifically during installation, construction, commissioning, qualification & validation phases.
• You may be involved with other aspects such as client-management (maintain key Client relationships in support of business development and pursuit of new work), project scheduling/budgeting, coordination of client and MMR resources for effective project delivery, supporting business development (providing technical support to the sales as required for proposals/opportunities), presenting at industry conferences/publishing papers etc.
• Visit construction and installation sites, wear necessary safety PPE.
• Supervise contractors during critical installations of process equipment and associated utilities.
• Other duties as assigned by client, and/or MMR, based on workload and project requirements.
• As this position requires working on client sites, you will need to comply with the client's safety rules including mandatory vaccination policies for COVID-19, where applicable.

Qualifications

• 10+ years of experience in engineering / project management of various equipment and facilities within the pharmaceutical/biotech industry, with knowledge of requirements for a cGMP operation.
• Sterile filling experience is required.
• Previous experience in Management of big capital projects is required.
• Possess leadership skills, and be able to take initiative to lead projects, involving multiple stakeholders, departments, and varying complexity.
• Possess mentorship skills, to coach and develop junior and intermediate employees.
• Basic knowledge of AutoCAD.
• Engineering degree, preferably in Mechanical, Chemical, Electrical Engineering.
• Certification in Project Management would be an asset.
• Travel may be required on occasion. Ability to travel to the US would be an asset.

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Equal Employment Opportunity and Reasonable Accommodations

MMR Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Our hiring decisions are based on merit, qualifications, and business needs. We are committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request.