At Nelson Laboratories, a Sotera Health Company, our employees are part of an industry-leading, global provider of sterility assurance, medical device evaluation services and expert advisory services.
Our employees receive competitive pay, growth and learning opportunities, insurance benefits, tuition reimbursement, paid holidays, time-off and the opportunity to attend many company-sponsored employee and family events.
Nelson Labs employees play a critical role in reaching our mission of: Safeguarding Global Health.
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.
Education and experience requirements:
Recommended Education and Experience
- Bachelor's degree required; Engineering/Science preferred.
- Three to five years of experience in Project or Program Management is required and FDA-regulated industry experience is highly preferred.
- Project management certification (such as PMP, CAPM, IFMA, LEED, or PgMP) preferred.
- IQ, OQ validation experience
- 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
- Six Sigma Black Belt highly desirable
- 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
- Project management experience articulating facilities/infrastructure subject matters.
- 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
- 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.
- 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
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.
Frequent travel during the business day to include out-of-the area with overnight travel may be expected
- 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