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Merck & Company, Inc.

Merck & Co., Inc. provides various health solutions through its prescription medicines, vaccines, biologic therapies, animal health, and consumer care products. The company provides human health pharmaceutical products, such as therapeutic and preventive agents for the treatment of human disorders in the areas of cardiovascular, diabetes and obesity, respiratory, immunology infectious diseases, neurosciences and ophthalmology, oncology, vaccines, and women's health and endocrine. It also ... Read More

Address      One Merck Drive PO Box 100 Whitehouse Station, NJ 08889-0100 United States
Website      www.merck.com/
Holding      No Holding Details

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Production Associate

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.

 

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.

 

The Production Associate performs various production and operations related tasks as part of an empowered team. Performs cleaning of Good Manufacturing Practice (GMP) space and equipment, operates and monitors equipment as deemed appropriate by skill level, provides materials and support needed to maintain equipment uptime, accurately and efficiently moves process materials in accordance with established procedures. Works in compliance with appropriate procedures, documentation, governmental regulations, safety programs, lean manufacturing principles and current good manufacturing practices (cGMPs).

 

Major Responsibilities:

 

Clean Room Cleaning/Materials Management (50% of time)

    * Performs tasks that require aseptic gowning.
    * Maintain clean rooms with appropriate cleaning and disinfection procedures. Includes mopping floors, walls and ceilings, wiping down equipment, removing trash and re-stocking supplies.
    * Maintains the equipment prep area.
    * Manages laundry including receipt and storage of clean garments, re-stocking of garments, and removal of dirty garments.
    * May initiate purchase of cleaning chemicals, components and other consumables to ensure supply/inventory of production support items
    * Move soiled equipment to equipment prep area for cleaning and/or sterilization.
    * Manages inventory levels in Supermarkets/Kanbans.
    * May coordinate w/ materials management and move filled vials from Vaccine Manufacturing Facility (VMF) staging area to cold storage in Materials Maintenance and Support Facility (MMSF).
    * May move stoppers to equipment prep for sterilization, then to filling for use.
    * Moves materials throughout Durham Facility and MMSF, as required. Includes operation of material handling equipment (forklifts, carts, hand trucks, etc).
    * Expected to lift and move various items up to 50 lbs.
    * In all work follows current good manufacturing practices (cGMPs), appropriate SOPs, safety programs, good documentation practices and other governmental regulations.
    * Follows lean manufacturing principles.
    * Performs CIP (Clean-In-Place) and SIP (Sterilization-In-Place) and associated skid activities in PSF (Pooling, Sonication & Filtration) Suite.
    * Performs Shell Freezing/-70 Freezer activities to support downstream processing.
    * Performs Grade A activities.
    * Participates in and assists with the development and execution of personnel training.
    * Demonstrates proficiency with Distributed Control System and other automated systems (including, but not limited to, SAP, MES, DeltaV, NG LIMS, HanDEL, Word, Excel)
    * Performs sampling/in-process testing supporting the manufacturing and validation process for current process as well as developmental work for new products/processes as required.
    * Schedules and performs environmental monitoring during processing and records results in the computerized database system.

Operations Support (40% of time)

    * Operates and/or monitors production support equipment to include but not be limited to: parts washers, autoclaves, portable tank CIP/SIP/storage panels, stopper processor, heat sealer.
    * Uses automated systems including MES and PLC based systems.
    * Manages equipment flow (reusable parts, tubing machines, portable tanks, stoppers) through the equipment wash and prep area. Includes tracking soiled and clean hold times, proper labeling and inventory management of clean and sterile equipment using Kanbans and using the automated MES system to set QC status and expiry of sterile equipment.
    * Picks-up, labels and delivers samples to appropriate sample storage locations.
    * Performs tasks as needed to support continuous operations to include but not be limited to: emptying trash, handling and remediating spills, performing as-needed cleaning, assisting with Technician activities.

Information Transfer (10% of time)

    * Receive training including safety, GMP, aseptic and process specific as required by the job
    * Perform duties based on Star Model including: first level resource issue resolution, initiate quality improvement ideas, participate in quality, safety and environmental investigations, HECP, HAZOP and equipment challenges, support development of SOPs and training materials.
    * Detect and communicate potential safety, environmental and compliance events
    * Recommend improvements in equipment uptime and personnel efficiency
    * May participate in regulatory inspections

Please note, this position requires the ability to work various shifts (evenings, overnights, weekends)
 
Qualifications
 

Education:

    * High School Diploma or GED

Required:

 

    * Prior experience cleaning equipment in a Good Manufacturing Practice (GMP) facility, OR have completed courses related to biotechnology (Bioworks).
    * Basic computer skills, including knowledge of Microsoft Office applications.
    * Position requires aseptic gowning during performance of job duties.  Aseptic gowning requires that all skin and hair are covered through wearing the following: beard/moustache cover, hari net, hood and facemask, goggles, jumpsuit, gloves and boots.

Preferred:

    * Prior experience working in a manufacturing environment.

Merck is an equal opportunity employer, M/F/D/V – proudly embracing diversity in all of its manifestations. Former Military, Transitioning Service Members, National Guard & Reserves - We value your past and present service.

 

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.
 

Other Job Information

Vacancy type:

Full Time

Contact Mode:

not provided

Fax:

+1-908-2987082

Contact Name:

not provided

Job Duration:

not provided

Phone:

+1-908-4231000

Email:

not provided

News - Merck & Company, Inc.

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