Kelly Services Operations Manager in Fort Collins, Colorado
Facilities, Operations & Validation Technical Manager ($96,000-120,000 annual)
Manages the procurement, installation, commissioning, qualification, and use of all Company production and analytical equipment. Has knowledge in managing equipment records and IOP qualifications for manufacturing related equipment in an FDA regulated environment. Requires expertise in project engineering, equipment commissioning and qualification, preventative and corrective maintenance activities, and instrument calibration. Will need expertise in GMP (good manufacturing practice) concepts, practices, and procedures. The ideal candidate will also have the ability to proactively manage equipment and facility-related concerns, including being able to make minor mechanical repairs, be able to work in BSL-3, think critically and make professional judgements with regard to personnel management, compliance, quality, and continuous improvement paradigms. Additionally, candidates ideally be able to clearly and efficiently communicate with others, investigate and report on incidents and provide intelligent corrective proposals, and report job outcomes in a timely manner to Directors and clients.
Duties and Responsibilities
Creation and oversight of complex equipment management systems and large numbers of instruments and equipment. Independently establish polices that support work efforts and lead to strict adherence to timelines, management of routine maintenance, instrument calibration, equipment commissioning, equipment installation, operation, and performance qualification.
Responsible for supervising the coordination of non-Company facility support.
Oversees activities (and may perform) cyclical preventative maintenance on all of Company equipment.
Independently analyze complex equipment performance data sets, summarize findings, perform risk analysis, and chart corrective actions. Must consistently exercise discretion and judgment to meet production standards in GMP environment.
Supervise all other Facilities and Operations team members including Facilities and Operations Supervisor, Associate and Student positions.
Continuously evaluate all associated Standard Operating Procedures, engineering specification, and various other controlled documentation for accuracy and applicability, and make improvements based on best practices.
Continuously evaluate and critique operations activities to eliminate nonproductive activities and implement productivity enhancements.
Takes responsibility for the management of all assets within the Company.
Interpret and apply best engineering practices in cooperation with a flexible approach to project requirements.
Ensure all assigned equipment is maintained in the following manner:
All Preventative maintenance and instrument calibrations are performed at the appropriate interval and are completed by the assigned due date.
All equipment remains in its designed and/or validated state at all times.
All equipment operation is in accordance with Federal, State, Local and Company regulations, procedures, and policies.
Complete all production-related activities in a safe and timely manner following all cGMP documentation guidelines.
Coordinate and instruct contractors/vendors who perform repairs, modifications, and installations of various equipment.
Work directly with Company Process Development, Manufacturing, and Quality departments on new system installations or modifications and maximize equipment availability.
Responsible for the operational readiness, calibration, qualification and validation status of equipment.
Establishes and/or maintains a controlled database for the documentation, trending and analysis of the performance readings (i.e., temperature readings, pressure readings, etc.) for critical equipment.
Create/implement/execute written documents such as User Requirement Specifications, detailed design specifications, equipment commissioning and qualification protocols (IQ/OQ/PQ), reports, SOPs, and other directive documents.
Completes sophisticated documentation requirements for all GMP activities following Good Documentation Practices (GDP). Must be able to justify all written records to Regulatory Auditors (e.g., FDA) in person.
Ensure/maintain all assigned equipment areas in a constant state of inspection readiness
Bachelor’s degree in Engineering or related field OR Bachelor’s degree in an unrelated field with 5 years of directly related and relevant experience OR Associate’s degree in an unrelated field with 10 years of directly related and relevant experience.
5 years of experience in a supervisory role of a Mechanical or related engineering group.
5 years of experience in the pharmaceutical industry
Experience in project engineering, equipment commissioning and qualification, preventative and corrective maintenance activities and instrumental calibration.
Expertise in GMP (good manufacturing practice) concepts, practices, and procedures.
Ability to obtain U.S. Government security clearances and Homeland Security CDC Select Agent Tier I clearance.
Experience in a contract manufacturing, pharmaceutical, or other regulated environment.
Experience in US code of federal regulation fields of GMP, GLP, GXP.
Biosafety Level 3 experience/or experience in a high containment facility
Why Kelly ® ?
Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.
About Kelly ®
At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm