- Location: Kalamazoo, Michigan
- Sector: Pharmaceutical
What’s In It For You?
- Recognition And Reward
- Inclusive And Diverse Culture
- Career Development And Progression
- Global Client Projects
- Global Travel Opportunities
- Benefits Especially For You – Medical And Dental Insurance, 401k Retirement Plan, Maternity/Paternity Leave, Training And Educational Assistance
- Work With The Most Innovative Technologies
About LotusWorks:
LotusWorks exists to support world-leading organisations with engineering and technical expertise for over 34 years. LotusWorks work in partnership with its clients specialising in Commissioning, Calibration and Operations and Maintenance work scopes.
Our 650+ strong staff work across 24 locations in EMEA & North America gaining exposure to the very latest technologies and innovations. At LotusWorks, we believe that embracing a diverse and inclusive culture is integral to our people first strategy. With people from 20 unique nationalities throughout our teams across the globe, we are proud of the diverse array of cultures and continuously ensure employees culture is recognised and celebrated throughout the business.
We lead by putting our people first and we are dedicated to supporting employees in developing their careers within the company, so that each LotusWorker can reach their full potential.
Your Job Purpose:
As a Commissioning, Qualification and Validation (CQV) Manager working with the LotusWorks Team, you will join our client site in the pharmaceutical sector. This job is based in a cutting-edge facility in Kalamazoo, Michigan.
As CQV Manager, you will be responsible for the oversight of the Commissioning, Qualification and Validation team and process at our client’s new facility. This is to ensure that it is being constructed, validated and operated in accordance to the clients global standards. This includes meeting all regulatory standard and requirements, GMP and GDP standards.
Your Job Description:
- Manages multiple and complex CQV projects, provides status reports and coordinate with other departments or outside contractors and vendors to complete tasks.
- Owns and supports technical and quality investigations.
- Develops and performs any required remediation efforts and associated CAPA plans
- Authors, owns and executes master and completed CQV protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria, specifically data integrity
- Executes, owns, assesses and participates in the creation, revision and review of change controls, SOPs, and other documentation
- Participates in authoring Risk Assessments, FMEAs, Periodic Qualifications, Project and Master Plans
- Works in a collaborative team setting with Quality, Manufacturing Operations, Facilities & Engineering Quality Control, Operations Technical Support, Supply Chain and Planning.
Job Requirements:
- Bachelor’s degree in engineering, Science or related field.
- 5+ years of experience in commissioning and qualification and validation of pharmaceutical facilities
- Strong knowledge of GMP regulations and FDA guidelines.
- Excellent communication, leadership, and project management skills.
- Ability to work in a fast-paced, dynamic environment and manage multiple projects simultaneously.
Proud To Be:
- People First Company
- Certified Commissioning Firm
- High Wire Safety
- LEED Accredited Projects
Benefits Just For You:
- Medical And Dental Insurance
- Life, Short-Term, Long-Term Disability Insurance
- Training And Educational Assistance
- 401k Retirement Plan
- Extra Annual Leave With Years Of Experience
- Maternity/Paternity Leave
- Recognition Rewards
LotusWorks is an Equal Opportunity Employer.
