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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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Process Engineer

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.
Position Overview
The IPT Process Engineer provides technical input on drug product processes from a facility and operational standpoint, and provides manufacturing project management oversight and GMP expertise to ensure timely availability of clinical supplies and development batches to meet Clinical Development program requirements. The incumbent is the main interface with development scientists regarding the activities required for the manufacturing of OSD and non-sterile liquid clinical and development batches in the manufacturing pilot plant.  The Process Engineer also ensures that clinical batches meet the compliance standards set by regulatory agencies and internal site procedures.
Additional responsibilities are as follows:

    * Provide technical input and partnership with formulation scientists for the manufacturing of drug product batches in the pilot plant including both GMP and Development batches.
    * Represent GPC Ops in Drug Development teams to provide manufacturing and compliance expertise.
    * Focal point for issue resolution for manufacturing issues within the pilot plant.
    * Act as main interface with Quality organization for manufacturing issues.
    * Manufacturing Project Management and Execution Oversight including:
          o Generating manufacturing execution project plans.
          o Responsible for coordination of all logistical requirements for batch manufacturing.
          o Organizing and running manufacturing project meetings with partner groups including formulations scientists, analytical scientists, quality, and clinical supply planning.
          o Generating batch documentation including batch records, protocols and summary reports.
          o Execution of orders and transactions within electronic inventory management and tracking systems (POMS based Clinical Supplies Tracking System). Examples include Bill of Materials, Recipes, Material IDs, etc.
          o Provides oversight on the floor during manufacturing operations for technical, project management, and compliance.
          o Provides project specific training and mentoring to manufacturing operators prior to and during manufacturing operations.
    * Accountable for closing out batch documentation to ensure release per site procedures and requirements including:
          o Review and assemble of batch documentation.
          o Conducting Investigations.
          o Completing Change Management records.
    * Participate in GMP and Safety audits as required.
    * Participate in equipment optimization or purchasing projects with Engineering team.
    * Develop and or update SOPs as required.
    * Participate/Lead in Lean Six Sigma and other Process Improvement Projects as assigned.
    * Responsible for keeping current with all training GMP and Safety training.

Educational requirements:

    * Bachelor of Science degree required in either chemistry, biology or a relevant engineering degree such as chemical engineering.  

Experience or Skills Required:

    * Technical Writing - including batch documentation, investigations, protocols
    * Knowledge of Manufacturing Equipment.
    * Good Manufacturing Practices.
    * Application of Compliance knowledge to manufacturing of clinical supplies.
    * Computer skills - Powerpoint, Excel, Project, and Word.
    * Area Policies and Procedures.
    * Communication skills both written and oral.  
    * Analytical Problem solving skills.

Experience or Skills Desired:

    * Drug Product Manufacturing and/or Formulation Development
    * Cross Functional Leadership and mentoring.  
    * Time Management.
    * Planning and Scheduling.
    * Continuous improvement skills.
    * Team meetings management.

 Business Skills:

    * Strategy Development
    * Project Management
    * Negotiation Skills
    * Presentation Skills

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.
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

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