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For your reference, we have included the original job posting below.
Director Environmental Monitoring Job
Job Number:
25573218
Company Name:
Merck
Job Location:
West Point, PA US
Job Categories:
Engineering & Architecture Manufacturing & Production
Director Environmental Monitoring Job
Director Environmental Monitoring-QUA002269
Description
Merck is a global health care leader with a diversified portfolio of prescription medicines, vaccines and consumer health products, as well as animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
Directs all aspects of internal environmental testing and monitoring support in the manufacturing, filling, component processing, sterile bulk, drug manufacturing areas, and clean rooms of the Merck Manufacturing Division (MMD) Vaccine and Sterile Production areas as well as testing in non-sterile areas at West Point to maintain compliance with applicable federal and international regulations. Works with divisional groups in developing policies and guidelines on all aspects of environmental monitoring, process simulations, personnel monitoring, and monitoring of utilities systems. Provides technical support for new MMD vaccine production sites. Manages a budget in excess of $10 million.
Reports to the Executive Director, West Point Quality Operations and oversees the performance of 70 or more exempt personnel who direct the activities of 50 or more hourly personnel at the West Point site.
Responsible for the performance, evaluation, and investigation of >700,000 individual tests annually which include routine and per-batch testing of room environments (viable/non-viable), , clean room surfaces, clean room personnel; sampling and testing of utility compressed gases and process water systems; certification of HEPA filtered HVAC systems. Management of the process simulation (media challenge) program.
In conjunction with MMD Engineering & Technology, provides planning recommendations, evaluations and approval of construction projects and equipment purchased for sterile product development and production with regard to environmental control aspects. Develops protocols/specifications and disseminates same for environmental control related equipment/projects/studies. Ensures department is well-versed in global regulations covering aseptic processing and environmental monitoring and takes appropriate actions to ensure compliance with emerging regulatory and industry trends. .
Supports new operations by assisting with the set up of environmental/utilities monitoring program and process simulation program at new vaccine and sterile production facilities in the Merck network. Partners with Divisional Quality to develop standards and guidelines related to environmental and utilities monitoring, personnel gowning, and process simulations.
Develops short and long-range plans for manning, facilities, and equipment to ensure achievement of area, section, and departmental goals. Maintains departmental records in compliance with company and regulatory standards. Responsible for departmental safety standards, maintenance and housekeeping. Recommends capital expenditures; responsible for development and operational control of department budget. Responsible for the facility decontamination program at West Point.
Qualifications
Education Required:
* B.S. in biological sciences, preferably microbiology or environmental biology. M.S. or Ph.D. desirable.
Required Experience:
* Seven to ten years of aseptic manufacturing experience. * Three to five years in microbiological testing, production, or technical services. * In-depth understanding of aseptic technique mandatory.
Desired Experience:
* Knowledge of global regulations covering aseptic processing and environmental monitoring is strongly desired. * Experience with managing a departmental budget is desirable. * Experience with detailed investigations with regard to microbial overlimits * Awareness of agency expectations of the Env Monitoring department * Experience implementing CAPAs (Corrective and Preventive Actions) * Strong partnering skills w/Ops group * Experience with people management * Knowledge of manufacturing processes (from GMP/Operational/Agency perspectives) * Experience in Media challenges * Experience in Optimize operations - business efficiency * Experience in automation systems (collecting and evaluating Environmental Monitoring data)
Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Merck's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.
to create a profile and your resume for requisition # QUA002269.
Merck is an equal opportunity employer, M/F/D/V - proudly embracing diversity in all of its manifestations.
Search Firm Representatives
Please Read Carefully:
Merck is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via-email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.
