Job Description
Are you a highly organized and analytical individual with a passion for quality and compliance? Do you have experience in HEPA certification performance or management? Are you looking for a challenging and rewarding role that allows you to make a positive impact on a global scale? We are seeking a motivated and experienced HEPA Certification Facilitator to join our team! As a HEPA Certification Facilitator, you will be responsible for coordinating and executing the HEPA certification program for all West Point facilities.
Under the supervision of an Associate Director or Director, the HEPA Certification Coordinator is responsible for HEPA Certification Schedule execution, for all West Point of our Manufacturing Division facilities. The coordinator will be part of a HEPA Certification management team. This team's primary responsibility is to collaborate with the various area stakeholders (manufacturing, maintenance, supply chain, etc.) to optimally plan, schedule and execute the site HEPA certification program, in a safe and compliant, manner. In this role, the certification coordinator actively ensures that execution of the quality, safety, environmental, and operating cost goals of the HEPA certification program are achieved.
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DUTIES
- Review the HEPA certification schedule. Collaborate with operations and maintenance personnel, to align HEPA technician resources, with equipment availability in the field. Drive work prioritization based on compliance requirements, work order due dates, business needs, cost, and backlog management.
- Manage daily HEPA technician activities, including leading LOTO execution. Have some basic knowledge of certification principles, to help facilitate completion of scheduled activities.
- Perform verification of HEPA Certification activities, per site procedures. Ensure that certifications are performed, and properly documented, per all GMP requirements.
- Support work order administration tasks, such as work order initiation, review, approval, and closure.
- Provide input for ensuring that CMMS/EAM data is up to date and accurate for HEPA equipment. Support maintenance of site HEPA filter inventory.
- Support management of HEPA certification equipment maintenance and calibration.
- Collaborate with operations and maintenance personnel, to incorporate HEPA certification activities into planned shutdown maintenance periods. Support all planning and scheduling activities, associated with shutdown activities. Manage execution and documentation of shutdown HEPA certifications.
- Communicate certification failures to the HEPA Planner/Scheduler and equipment owners. Collaborate with our Company resources, in the performance of remediation activities. Ensure that HEPA technician activities are properly prioritized, in accordance with site and business needs, during remediation and recertification activities.
- Participate in HEPA technician training, to ensure that HEPA technicians are proficient in our Company procedures, and that all training is completed in a timely manner (safety and GMP training).
- Support reconciliation of monthly work orders to confirm all HEPA filter certifications are completed per PM due dates. Ensure accuracy of GMP documents. Conduct routine field evaluation of service providers.
- Support development of KPIs related to HEPA scheduling and work execution, along with Communication of KPIs to stakeholders. Analyze KPIs and support continuous improvement to the planning, scheduling, and execution processes.
- Provide data for HEPA failure investigations and participate in problem solving activities. Support the development of actions related to increased reliability of HEPA related equipment.
- Collect feedback from HEPA technicians to improve job plans. Provide feedback to Engineering support group and follow up on required changes.
- Assist in the HEPA Certification Program portion of internal audits and regulatory inspections, as required.
Education Minimum Requirement:
- B.S. or B.A in a technical field., OR relevant industry experience managing or executing HEPA certifications in GMP facilities.
Required Experience and Skills:
- Six (6) years of experience in one or a combination of the following:
- HEPA certification performance or management
- Manufacturing, operations, supply chain, military, or other industries (education beyond HS will be counted as relevant experience).
- Highly organized, analytical, motivated to drive positive change, detail oriented, and is capable of being influential outside of his/her functional group.
- Strong computer skills. Experienced in using Computerized Management Maintenance Systems, Excel, SAP, or equivalent database/spreadsheet systems.
- Proficient in the following competencies: communication, teamwork/collaboration, problem solving, empowering leadership, project management, and flexibility.
Preferred Education, Experience and Skills:
- Expertise in HVAC systems, supporting qualified manufacturing facilities.
- Management of 3rd party/contract resources
- Working Knowledge of cGMPs for pharmaceutical and/or vaccine manufacturing, Lean Six Sigma Methodology, Root Cause Analysis, Failure Mode Effects Analysis, knowledge in reliability engineering (including asset life cycle management)
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US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
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U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Not Applicable
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
11/19/2024
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID:R321136