Nelson Labs is a leading global provider of microbiological and analytical lab testing, provides support to all aspects of the manufacturing and facilities maintenance, while providing a safe and quality focused environment for employees. The Project Manager will provide support to all departments and will interact with vendors, contractors, and other personnel in a professional manner. The Facilities Project Manager will manage projects to include scope development, design inputs and reviews, scheduling, and managing budgets. They will also assist in scheduling qualifications and validations, providing timely communication with senior management/employees.
Three to five years of experience in Project or Program Management is required
Experience in either Manufacturing, Product Development / R&D, Process Engineering, Product Management, Supplier Quality
Knowledgeable and experience in layouts, Construction and Design Management Regulations
Knowledgeable and experience in Management of Construction contracts
Preferred Experience (note required):
FDA-regulated industry experience
Project management certification (such as PMP, CAPM, IFMA, LEED, or PgMP)
Six Sigma Black Belt highly desirable
IQ, OQ validation experience
Essential Duties:
Will manage projects including scope development, design input and reviews, scheduling, managing budgets, selection and supervision of contractors, qualifications and validations, and communication with senior management/employees.
Will meet company regulatory requirement, including change control.
Ensure projects are on time and in budget.
Track progress of projects against goals, tasks, timelines, and budgets. As issues arise, communicate risks and mitigations.
Identify resource needs and work with managers to secure and schedule project resources.
Facilitate project meetings with clear responsibilities and timelines.
Present/submit capital expense approval requests for management review.
Provide status updates as well as ongoing communication regarding projects to stakeholders
Develop project scope definition and coordinate with consulting architecture/engineering firms in developing design criteria and preparing layout and detail drawings. Prepare bid documents, and assist with contracts for construction and facilities acquisition including reviewing and estimating costs of design, equipment, installation, labor, materials, preparation, and other related costs
Directs the inspection of construction and installation progress to ensure conformance to established drawings, specifications, and schedules. Actively manage suppliers/vendors and hold them accountable for providing services per the scope of their contract.
Anticipate potential cost overruns and provide justification and supporting documentation with manager, as well as develop alternative construction/design solutions and makes recommendations for cost containment, as appropriate
Responsible for new construction and tenant improvement projects include ensuring code compliance, safety, permitting, monitoring quality and building commissioning prior to occupancy
Complete project tasks as an individual contributor
Knowledge of architectural design, construction principles, facility operations and related services
Working knowledge of construction trades, especially electrical, plumbing, and HVAC
Proficiency with all Microsoft Office applications, especially Microsoft Project
Proficient with AutoCAD and/or Solid Works
Project management background/experience with construction projects
Knowledge of building codes, NFPA, and OSHA
Financial background/experience
Regulatory Compliance
Know and follow applicable regulatory requirements (GMP, GLP, ISO, etc.).
Know and follow company policies and procedures.
Complete required training on time.
Knowledge and experience with labs, clean rooms and supporting infrastructure, particularly within a medical device or pharmaceutical manufacturing environment.
Professionalism
Attend work regularly and reliably.
Adhere to all policies and procedures.
Perform other duties as assigned
Competencies of this position
Ability to self-direct, manage priorities and organize time
Strong ability to complete projects within scope, budget, and on time based on project objectives and aligned with strategic priorities
Experience with a variety of utility systems.
Experience with understanding technical issues in enough detail to effectively articulate design concerns to engineers, program managers, and senior management
Experience in developing and managing effective and trustworthy relationships with clients, contractors, and multi-disciplined architectural and engineering teams.
Experience working with internal customers - individuals and groups - to identify and communicate requirements, develop scopes of work, and set priorities to meet customer goals.
Ability to assess facility needs, plan to address those needs including improvements and upgrades to support internal customers.
Ability to significantly contribute to utility system designs, leveraging 3rd parties as needed.
Ability to develop gross design and construction cost estimates
Experience with the installation and maintenance of clean rooms
Understanding of space and cleanroom classifications
Proven ability in listening and interpreting internal customer and stakeholder project requirements and translating concepts to functional design objectives
Customer Service Skills
Strong Communication, Presentation Skills
Time Management Skills
Problem Solving Skills
Attention to Detail
Able to multi-task and be self-motivated
Available for afterhours support
Work Environment:
This job operates in a professional office and laboratory environment this may include, office, laboratory, warehouse, or clean-room environment or working outside. Work may also involve areas under construction.
PPE may be required such as respirators, clean room attire, welding mask, Arc Flash clothing, etc. May be required to work in extreme high/low temperatures, extreme high/low noise levels, working at heights, or on slippery or uneven surfaces. Will climb ladders and work off elevated surfaces on a frequent basis.
Travel requirements.
Frequent travel during the business day to include out-of-the area with overnight travel may be expected
Physical requirements:
Must be able to move/traverse 80% of the day and remain in a stationary sitting/standing position at a desk while using a computer, keyboard, computer mouse and phone 20% of the day.
This position occasionally moves or lifts items greater than 75lbs.
Wear personal protective equipment such as hoods, lab coats, safety glasses, goggles, gloves, facemasks, shoe coverings, and respiratory equipment as applicable.
Climb up onto and down from equipment.
Climb up and down ladder.
Able to manipulate small hand tools
Must have excellent balance
Ability to pass cleanroom gowning qualification
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company's unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a leading global provider of mission-critical sterilization and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry recognized scientific and technological expertise, we help to ensure the safety of millions of patients and healthcare practitioners around the world every year. Across our 64 facilities worldwide, we have over 3,000 employees who are dedicated to safety and quality. We are a trusted partner to more than 5,800 customers in over 50 countries, including more than 40 of the top 50 medical device companies and 8 of the top 10 global pharmaceutical companies.
Sotera Health goes to market through its three best-in-class businesses - Sterigenics®, Nordion® and Nelson Labs®. Sterigenics is a leading global provider of outsourced terminal sterilization and irradiation services for the medical device, pharmaceutical, food safety and advanced applications markets. Nordion is the leading global provider of Co-60 and gamma irradiators, which are key components to the gamma sterilization process. Nelson Labs is a global leader in outsourced microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries. Learn more about Sotera Health at soterahealth.com.
