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Senior Lyophilization Specialist for Vaccine Manufacturing

Merck


Location:
Elkhorn, NE
Date:
07/20/2017
2017-07-202017-08-19
Job Code:
MAN004347
Merck
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Job Details

Job Title: Senior Lyophilization Specialist for Vaccine Manufacturing  - MAN004347

Description

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its 125-year legacy. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Merck’s Animal Health (MAH) division works to improve the health of animals around the world through collaborative partnerships and a deep sense of responsibility towards our customers, consumers, animals, society, and our planet. This team of energetic, independent thinkers offers one of the industry’s most innovative portfolios of products, services, and technologies that serve to prevent, treat, and control diseases across all major farm and companion animal species both domestically and internationally.

 

This position is responsible for freeze drying vaccine batches in careful compliance with established operating procedures. Perform other departmental duties as required – i.e. CIP, SIP, cleaning protocols, sanitization, documentation, root cause analysis, trouble shooting and problem solving, etc.

  • Make certain a safe work environment by following all safety procedures, including any personal protective equipment (PPE) and standard operating procedures (SOP's) applying to a particular process or area.
  • Complete required batch documentation records with accuracy and legibility (verifying item codes, expiration dates, lot numbers, weights, descriptions, etc.).
  • Perform work associated with CIP, SIP and Aseptic processing to support final filling and freeze drying.
  • Ensure product quality by performing in-process checks, complying with current good manufacturing practices (cGMP’s), being alert for any deviation to a process, initiating quality improvements and participating on quality improvement projects.
  • Supervises a manufacturing staff in proper operating techniques and procedures.
  • Act as liaison between Managers, Quality Assurance team members, Research, Tech Services, Engineers and Maintenance personnel in matters regarding freeze drying.
  • Participate on manufacturing project teams to assist with Cycle development through collaboration with R&D and BTS departments.
  • Review work scope, rationale, approvals, changes to appropriate equipment/systems and re-qualification activities through Reliance
  • Contact parties involved for clarification when required.
  • Performs or develops preventive maintenance as required.
  • Assists in establishing production schedules.
  • Review CMMS Work Order completion documentation, attachments, signatures, and dates and communicate with appropriate parties to seek clarification/completion, as needed.
  • Perform environmental monitoring in areas as required.
  • Arrange for and schedule contract support as needed to complete corrective and preventative tasks.
  • May assist in the training of operators or cross-training in other areas.
  • Troubleshoot and perform adjustments on equipment as required.
  • Trained to perform Lock Out/Tag Out of equipment as needed.
  • Performs other hybrid duties within the downstream processing team as designated by management which may include, but is not limited to: final product packaging, capping, freeze drying, cycle counting, autoclaving, etc.
  • Help build team-oriented culture by motivating and supporting team members by sharing knowledge with all team members to continuously improve the process.
  • Work involves exposure to time pressures, frequent change of tasks, performing multiple different tasks within the same shift, tedious and detailed work in a fast paced environment. Able to work closely with others as part of a team as well as autonomously at times.
  • Take ownership of personal training and learning to develop skills to continuously improve.

 



Qualifications

Education:

  • Bachelor’s degree or equivalent

Required:

  • 5 years of experience in cGMP regulated industry.
  • 5 years combination of education, training, and experience with refrigerant and LN2 based Lyophilization.
  • 2 years supervisory experience in a pharmaceutical or food plant or equivalent experience and education.
  • Strong English reading/comprehension skills required to understand detailed SOP and Manufacturing Instructions. Ability to read and understand chemical labeling and warnings.
  • An understanding of aseptic techniques and procedures.
  • Basic mathematical skills - ability to use both U.S. customary and metric systems.
  • Proven ability to work safely in a production environment. Ability to wear personal protective equipment (hair net, beard net (if applicable), safety glasses and leather skid resistant shoes/boots).

Preferred:

  • Bachelor’s degree in Veterinary Technology, Biology or related science.
  • 10 year’s combination of education, training, and experience with refrigerant and LN2 based lyophilization
  • Experience with RSView and or Ifix freeze dryer operating systems.
  • Strong understanding of manufacturing procedures, techniques and equipment.
  • Demonstrated project management skills
  • Ability to lead teams
  • Excellent problem solving and decision making skills
  • Strong attention to detail and documentation skills. A demonstrated ability to follow written instructions precisely.
  • Ability to communicate and work in cooperation with other employees in manufacturing.
  • Inventory control concepts strongly preferred.
  • Proficient in Microsoft Office. Experience with RSView, Ifix, SAP, etc.
  • An adaptable, flexible, dependable, team player with strong communication, learning, self-managing and decision-making skills that wants to be a leader in safety and compliance in a dynamic and growing manufacturing environment
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.
Visa sponsorship is not available for this position
For more information about personal rights under Equal Employment Opportunity, visit:




Job Manuf./Operations Generic

Primary Location NA-US-NE-Elkhorn

Other Locations 

Employee Status Regular

Number Of Openings 1

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