Job Info
Hiring Senior Project Manager - Commissioning, Qualification, and Validation
(Pharmaceutical/Biotech)-Competitive Salary, Work/Life Balance!
We offer Full and Part-Time W-2, 1099, and C2C Opportunities
Previous Pharmaceutical/Biotech/Medical Device experience is mandatory for these roles.
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 CQV Senior Project Manager for our pharmaceutical manufacturing, biotech, and medical device client projects? Do you enjoy traveling the country and making a difference? If so, this could be the right opportunity for you!
The CQV Senior Project Manager will work closely with the client to provide innovative solutions to our clients. We are experiencing growth as a firm and are seeking a qualified senior project manager at several project sites nationwide. The ideal candidate will be a self-starter who takes pride in their work and actively pursues opportunities to learn and assist others when needed.
Responsibilities:
- Responsible for promoting the services of Compli to Life Science clients.
- Provide technical guidance on CQV and start-up of various pharmaceutical/biopharmaceutical cGMP process equipment, utilities, and facilities
- Lead the development of key project deliverables such as VMP, DQ, FAT, SAT, IQ, OQ, and PQ during the project lifecycle
- Supervise personnel while performing field execution of qualification test cases and protocols ensuring timely completion of all project deliverables.
- Possess knowledge of relevant regulatory requirements and industry best practices on all or any of the following - Process equipment, clean utilities, automation systems, laboratory equipment, information systems, buildings, and facilities.
- Coordinate meetings with cross-functional departments to drive project progress, facilitate decisions and provide updates.
- Able to manage (schedule, budget, resources) and execute multiple projects to meet client's priorities.
- Individuals must represent Compli at client sites as well as with industry-related societies and interact confidently with clients, contractors, management, and peers.
- Work may require occasional support over shutdowns or extended hours, specifically during commissioning, qualification, and validation phases.
- You may be involved with other project aspects such as client management (maintaining key Client relationships in support of business development and pursuit of new work), project scheduling/budgeting, and coordination of clients for effective project delivery.
- Support business development, providing technical support to sales for proposals/opportunities as required.
Requirements: - Minimum 10 years experience in commissioning, qualification, and validation of various systems within the Pharmaceutical, biotech, and medical device industries. Previous project management experience is a plus.
- Experience with developing/executing validation projects to Risk-Base CQ approaches, such as ASTM E-2500 or ISPE ICQ is an asset.
- Ability to work independently or in collaboration with others
- Proficient in current Good Manufacturing Practices and other applicable regulations
- Excellent written communication skills with emphasis on technical writing
- Proficient in MS Excel, MS Word, MS Project, and, MS PowerPoint
- Considered a Subject Matter Expert (SME) in multiple areas of validation
- Must be willing to travel regionally and/or nationally throughout the U.S.
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, Missouri, St. Louis, MO, commission, qualification, validation, CQV, DQ, FATs, SATs, IQ, OQ, PQ, PVPs, URs, RTMs, CPPs, VPPs, Project Validation Plans, Lead qualification processes, Senior Project Manager CQV, MMR, Pharmaceutical, Pharma, Biotech Industry, cGMP, Risk-based commission & qualification.
This job has expired.