We are currently seeking a Validation Manager to be responsible for managing a team of Validation Engineers. The team will be charged with conducting and delivering analytical and engineering studies to support cleaning validation, cleaning verification, thermal sterilization, thermal sanitization, and controlled temperature unit mapping for major GMP clinical and commercial equipment and facilities. The manager and team will write, approve, execute, and close-out validation reports; maintain GMP status of assigned suite areas and facilities; be responsible for project management to set and meet lead times for cleaning and sterile validation testing, elevate need for additional resources, and ensure equipment periodic revalidations stay on schedule.
Plans, implements, coordinates and manages all mechanical operations, maintenance, communications, energy management, and manpower development programs for a facility, campus or portfolio of buildings.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Manages technical staff, including hiring, training, personnel development.
Manages operations and maintenance for assigned facilities and assists in development of operating and capital budgets.
Assists in operations and maintenance issues, troubleshooting and problem solving as required.
Recommends/implements improvements for preventive maintenance programs on an on-going basis and develop/maintain effective building-specific maintenance and safety procedure manuals.
Coordinates maintenance efforts with outside contractors, tenant finish personnel and technicians. Oversee all building systems including fire/life safety, plumbing, HVAC and electrical issues and must remain current with latest HVAC technology trends.
Maintains on-going communication with tenants, clients, owners, facility management team and vendors.
May assist in solicitation and acquisition of new management contracts and coordinate development of and/or maintain as-built drawings.
Responds to emergency situations (fire, evacuation, equipment failure etc.) and customer concerns.
Implements and administers inventory control programs/purchase parts and supplies.
Develops specifications and assists in solicitation and administration of maintenance/repair service contracts.
Ensures compliance with applicable codes, requisitions, government agencies and company directives as relates to building operations.
Responsible for managing a small team of engineers who will conduct validation studies of major process equipment in vaccines and biologics manufacturing facilities.
Coordinate with Operations and Technical Operations to develop overall schedules for validation testing and coordinate daily testing schedules for team members.
Track testing completion and documentation status and communicate these details to the client stakeholders.
Conduct field cleaning validation testing including performance of visual inspection, and the collection of rinse water samples, swab samples, and/or extraction samples. Equipment will include: bioreactors, fixed tanks, transfer lines, chromatography skids, filtration skids, portable vessels, centrifuges, homogenizers, ultrasonic washers, glasswashers, lyophilizers, vial washers, chromatography columns, filter carts, and filter housings.
Conduct thermal validation testing using thermocouple sensors and data collection instruments on equipment including GMP autoclaves, decon autoclaves, waste inactivation systems, dry heat ovens, lyo cabinets, bioreactors, holding tanks, portable tanks, transfer lines, and controlled temperature units (CTUs).
All work includes protocol generation, Lock Out/ Tag Out, testing, report write-up, review, approval, and closeout.
Lock Out/ Tag Out participation is to ensure zero energy of equipment and permit safely breaking into lines for testing.
Practice highest regard for Safety: Work with potentially dangerous systems, some which utilize high pressures and temperatures.
Act as Subject Matter Expert (SME) on periodic re-validation of commercial product equipment and manufacturing.
Possess ability to answer validation questions and interact with various regulatory agencies.
Act as validation reviewer for operation's SOP's with validation cycle parameters and possess ability to quickly address operations' issues with equipment validated cycles.
Other duties as assigned.
Provides formal supervision to individual employees within single functional or operational area. Approves subordinate's recommendations for staff recruitment, selection, promotion, advancement, corrective action and termination. Effectively recommends same for direct reports to next level management for review and approval. Plans and monitors appropriate staffing levels and utilization of labor, including overtime. Prepares and delivers performance appraisal for staff. Mentors and coaches team members to further develop competencies. Leads by example and models behaviors that are consistent with the company's values.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and EXPERIENCE
Bachelor's degree (BA/BS) from four-year college or university and a minimum of four years experience and/or training. Or equivalent combination of education and experience. Knowledge and understanding of all applicable practices and techniques, laws, project controls and environmental regulations to include safety regulations.
8+ years relevant experience in pharmaceutical validation testing discipline.
Strong interpersonal skills and problem-solving ability.
Demonstrated leadership and teamwork skills, excellent analytical abilities, excellent written and verbal communication skills.
Proven record of providing excellent internal and external customer service.
CERTIFICATES and/or LICENSES
Universal CFC certification. Certification / license in two or more of the following is desired, and certain certifications may be required by local / state jurisdiction: electrical, mechanical, HVAC and refrigeration systems, boiler, plumbing. Facilities Management certification is desired.
Ability to comprehend, analyze, and interpret the most complex business documents. Ability to respond effectively to the most sensitive issues. Ability to write reports, manuals, speeches and articles using distinctive style. Ability to make effective and persuasive presentations on complex topics to employees, clients, top management and/or public groups. Ability to motivate and negotiate effectively with key employees, top management, and client groups to take desired action.
Requires in-depth knowledge of financial terms and principles. Ability to calculate complex figures. Ability to forecast and prepare budgets. Conducts financial/business analysis including the preparation of reports.
Ability to solve advanced problems and deal with a variety of options in complex situations. Requires expert level analytical and quantitative skills with proven experience in developing strategic solutions for a growing matrix-based multi-industry sales environment. Draws upon the analysis of others and makes recommendations that have a direct impact on the company.
OTHER SKILLS and ABILITIES
Intermediate skills with Microsoft Office Suite, Outlook, and intranet/internet. Ability to use work order system.
Working knowledge and understanding of architectural, electrical and mechanical systems. Understanding of leases, contracts and related documents.
SCOPE OF RESPONSIBILITY
Decisions made with in-depth understanding and interpretation of procedures, company policies and business practices to achieve general results. Responsible for setting department deadlines. Errors in judgment may cause long-term impact to co-workers, supervisor, department and/or line of business.
Responsible for personal safety and the safety of those who are affected by your work. This includes but is not limited to: 1. Complete all required and assigned HSE training at a satisfactory level, 2. Follow all activity policies and procedures, including all HSE-related requirements at all times, 3. Participate in all HSE-related programs & activities as required, including incident investigations, interviews, auditing and assessment, etc. 4. Report any conditions which you feel could result in an accident or injury and / or stop work if required.
As a Manager: 1. While adhering to all HSE requirements established for CBRE employees, supervisors and managers are additionally required to: a. Provide sufficient distraction-free time for employees to complete all required HSE training & support the HSE training program implicitly, b. Investigate and resolve (if possible) all reported unsafe conditions / acts and communicate results back to the affected stakeholders, c. Support "stop work" authority when it is exercised in good faith, d. Communicate any / all potential workplace hazards and workplace procedures.
Internal Number: 20000059
With broader and deeper capabilities than any other company, CBRE is the leading full-service real estate services and investment organization in the world.
CBRE Group, Inc. is the world’s largest commercial real estate services and investment firm, with 2017 revenues of $14.2 billion and more than 80,000 employees (excluding affiliate offices). CBRE has been included in the Fortune 500 since 2008, ranking #214 in 2017. It also has been voted the industry’s top brand by the Lipsey Company for 17 consecutive years, and has been named one of Fortune’s “Most Admired Companies” in the real estate sector for six years in a row. Its shares trade on the New York Stock Exchange under the symbol “CBRE.”
CBRE offers a broad range of integrated services, including facilities, transaction and project management; property management; investment management; appraisal and valuation; property leasing; strategic consulting; property sales; mortgage services and development services.