Job Info
Project Engineer with CQV Experience
(Pharmaceutical/Biotech)-Competitive Salary, Work/Life Balance!
We offer W-2, 1099, Agency Opportunities
Must be willing to travel
Previous Pharmaceutical/Biotech/Medical Device Sr.PM experience is mandatory
Are you looking to be a part of a close-knit work community? Do you have experience in the Life Science industry? Will you represent Compli, LLC as a Project Engineer with CQV experience for our client projects? Do you enjoy traveling the country and making a difference? If so, this could be the right opportunity for you!
Compli LLC is a full-service regulatory compliance consulting services company with a life sciences division specializing in pharma, biotech, API, Medical devices, and laboratory facilities. We are seeking an experienced Senior Project Manager with CQV Experience to join our growing team.
Responsibilities:
- Function as an owner's representative and report to the client's management lead
- Coordinate internal and external resources for the flawless execution of projects
- Ensure that all projects are delivered on time and within scope.
- Assist in the definition of project scope and objectives, involving all relevant stakeholders and ensuring technical feasibility
- Ensure resource availability and allocation
- Develop a detailed project plan to monitor and track progress
- Manage changes to the project scope, project schedule and project costs using appropriate verification techniques
- Measure project performance using appropriate tools and techniques
- Manage the relationship with the client and all stakeholders
- Perform risk management to minimize project risks
- Establish and maintain relationships with third parties/vendors
- Meet with clients and clarify specific requirements of each capital project
- Track project performance, specifically to analyze the successful completion of short and long-term goals. Meet budgetary objectives and adjust project constraints based on financial analysis
- Develop spreadsheets, diagrams, and process flow maps to document project requirements
- Perform other related duties as assigned
Requirements: - Bachelor's degree in an engineering field; preferably mechanical engineering or construction management
- At least ten years of pharmaceutical engineering and capital project management experience
- Able to handle multiple projects where the total project's values exceed $100MM.
- Ability to converse about biologics and pharmaceutical manufacturing topics
- Ability to work independently or in collaboration with others
- In-depth understanding and application of project management principles, concepts, practices, and standards
- Proficient in current Good Manufacturing Practices and other applicable FDA, USDA, and EU regulations
- Excellent client-facing relationship-building skills
- Excellent written and verbal communication skills
- Solid organizational skills including attention to detail and multitasking skills
- Proficient in MS Excel, MS Word, MS Project, MS PowerPoint, MS Access, and AutoCAD Lite.
- Must be willing to travel regionally and/or nationally throughout the U.S.
- Job assignments may require temporary relocation for up to 12 months or more
Preferred Qualifications: - P.E. - Professional Engineering License a plus
Preferred Qualifications: - PMP - Project Management Professional.
Compli, LLC was founded in 2001 to provide commissioning, validation, and regulatory support services to the life sciences industry. We serve pharmaceutical companies across the U.S. Regarding regulations and compliance, it has never been more important to understand the documentation and quality assurance activities as they relate to vendors, engineering, construction, and contractors, which is why clients trust the Compli team.
Perks of the Job: - Competitive Pay commensurate with experience
- Work / Life Balance
- Working with a small, close-knit team where you are valued as an individual
- A learning environment and continuous advancement opportunities
Feel overqualified? Feel underqualified? Apply anyway if this sounds like the fit you are looking for! We have flexibility in how we hire the role.
To learn more and APPLY NOW:
http://www.ucompli.com/careers Agencies, Compli welcomes your qualified candidates. Please email:
compli-opportunities@ucompli.com to establish a relationship with our firm.
We are an equal opportunity employer M/F/D/V Job Keywords: Unites States, Lenexa, KS, Kansas City, KS, Overland Park, KS, Olathe, KS, commission, qualification, validation, CQV, DQ, FATs, SATs, IQ, OQ, PQ, PVPs, URs, RTMs, CPPs, VPPs, Project Validation Plans, Lead qualification processes, Senior Project Engineer, CQV, MMR, Pharmaceutical, GMP Pharma, Biotech Industry, Risk-based commission & qualification.
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