- Provide strategic oversight and management of large complex capital manufacturing system projects in the US
- Responsible for project initiation, planning, execution, monitoring, and closeout
- Collaborate with internal Donaldson stakeholders, external suppliers and contractors, and customers to ensure project success
- Ensure systems are capable of meeting customer requirements and any state/federal/regional regulatory requirements and corporate policies/standards (cGMP, ISO 9001/13485, UL, ASME-BPE).
- Manage and coordinate contract activities, including those at customer sites, to ensure positive relations while representing the interests of the company
- Communicate project status and progress to project teams, Donaldson Management, and other stakeholders
- Prepare and maintain project documents, budgets, and schedules
- Bachelor's degree in Engineering or Technical field
- Minimum 15 years of progressive project management experience with 8+ years within complex bioprocess or hardware projects
- Knowledge of state, federal and corporate policies/standards related to bioprocess systems design, manufacture and operation (cGMP, ISO 9001/13485, UL, ASME-BPE).
- Knowledge of bioprocessing systems and/or hardware, including experience managing customer-specific designs and process requirements
- Proven project leadership qualities (setting pace, decisiveness, change management, ability to influence and communicate at all levels of the organization, organizational awareness)
- Excellent interpersonal and communication skills
- Ability to prioritize projects concurrently in a dynamic environment
- PMP/PMI Certification
- Experience with manufacturing equipment and operational systems / facilities for bioprocessing systems and production, including cleanroom-based processing
- Experience working directly with customers in FDA regulated industries including peptides, bioprocessing, engineered proteins, vaccines, pharmaceuticals, and related life science industries.
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Principal Project Manager - Bloomington, United States - Donaldson Company
Description
Donaldson is committed to solving the world's most complex filtration challenges. Together, we make cool things. As an established technology and innovation leader, we are continuously evolving to meet the filtration needs of our changing world. Join a culture of collaboration and innovation that matters and a chance to learn, effect change, and make meaningful contributions at work and in communities.
Donaldson's decades of expertise developing and manufacturing products for life science industries has led to our recently created business vertical, Life Sciences; focus on accelerating solution that improve lives through Bioprocessing, Biopharma, Medical Devices, Food & Beverage, Microelectronics and Clean Energy. To learn more out Donaldson Life Science and our diverse technologies click on the following links:
Donaldson Liquid Filters for Food and Beverage Applications - YouTube
Solaris Biotech Solutions video Corporate - YouTube
We are searching for an experienced Principal Project Manager - Bioprocess Systems to lead the development of manufacturing processes for bioprocess systems. In this role you will provide leadership and direction to multifunctional teams through the planning and execution of bioprocess equipment manufacturing to meet customer and regulatory requirements.
Your role is required to assure compliance of Company's operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including knowledge of all standards, government occupational health and environmental regulations and statutes related to the site).
Role Responsibilities:
Minimum Qualifications:
Preferred Qualifications:
Travel: Ability to travel domestically and internationally, 20%
This role will be based at the Bloomington, MN headquarters with possible travel to customer sites and supplier locations primarily in the US West Coast.
Key words: bioprocess systems, project management, engineer, ISO, cGMP, PMP, PMI, FDA
#LI-Hybrid
Employment opportunities for positions in the United States may require use of information which is subject to the export control regulations of the United States. Hiring decisions for such positions are required by law to be made in compliance with these regulations. Applicants for employment opportunities in other countries must be able to meet the comparable export control requirements of that country and of the United States.
Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.
Donaldson is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, age, gender, religion, national origin, genetic information, protected veterans status, sex, sexual orientation, gender identity, disability status, or any other status protected under federal, state or local laws.