Job DescriptionAre you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you.Under the supervision of an Associate Director or Director, the HEPA Certification Planner/Scheduler is responsible for managing the HEPA Certification Program, for all West Point Manufacturing Division facilities. The Planner/Scheduler will proactively review upcoming HEPA certification requirements, work with the various area stakeholders (operations, maintenance, etc.) to plan upcoming HEPA certification activities, develop, and manage, monthly HEPA certification schedule, drive work prioritization, and collaborate with the 3rd party service provider, to manage the HEPA certification team, in the proper execution and documentation of all HEPA certification activities. In this role, the planner/scheduler actively ensures GMP quality, safety, environmental, and operating cost goals of the HEPA certification program are achieved.DUTIES
Utilize the site CMMS computer software, and other computer applications, to manage the HEPA Certification Process. Execute work order administration tasks, such as initiation, review, approval, and closure, as required.
Review the forecasted HEPA certification plan. Collaborate with operations and maintenance personnel, in support of Planning activities for upcoming HEPA certification activities.
Collaborate with equipment owners, to develop a monthly certification schedule. Collaborate with 3rd party provider, to provide HEPA technician resources, in accordance with the requisite workload.
Drive work prioritization based on compliance requirements, work order due dates, business needs, cost, and backlog management. Collaborate with operations and maintenance personnel, to incorporate HEPA certification activities into planned shutdown maintenance periods. Finalize, and publish, the work schedule for all affected organizations.
Coordinate work assignments for HEPA certification technicians daily. Have some basic knowledge of certification principles, to help facilitate completion of scheduled activities.
Communicate certification failures to the equipment owners, and relay requests for the company resources, required for remediation activities. Manage prioritization of HEPA technicians, to ensure that recertification activities are properly aligned with operational schedules and PM work.
Ensure that HEPA technicians work within procedures and practices to achieve objectives and meet deadlines. Monitor HEPA technician training, ensuring that all training is completed in a timely manner (safety and GMP training).
Complete 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.
Generate KPIs related to HEPA scheduling and work execution. Communicate KPIs to stakeholders; analyze KPIs and support continuous improvement to planning and scheduling processes.
Provide data for HEPA failure investigations and participate in problem solving activities.
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, Technical support, Planning, or Scheduling.
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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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”.Search Firm Representatives Please Read CarefullyMerck & 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:RegularRelocation:No relocationVISA Sponsorship:NoTravel Requirements:No Travel RequiredFlexible Work Arrangements:Not ApplicableShift:1st - DayValid Driving License:NoHazardous Material(s):n/aJob Posting End Date:09/30/2024A 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.Job Posting End Date: 09/30/2024A 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: R311850