Senior Lyophilization Specialist
- Omaha, NE
Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.
This position is accountable for freeze drying vaccine batches in careful compliance with established operating procedures and production outlines. Perform other departmental duties as required - i.e. Clean in Place (CIP), Steam in Place (SIP, cleaning protocols, sanitization, aseptic filling, capping, 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 process or area are followed.
- 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 external departments.
- Review work scope, rationale, approvals, changes to appropriate equipment/systems and re-qualification activities through Reliance. Contact parties involved for clarification as necessary.
- Performs or develops preventive maintenance as necessary.
- 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 necessary.
- 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.
This is a 1st shift position M-F.
- Bachelor's degree or equivalent in Veterinary Technology, Biology or related science.
- 5 years of experience in cGMP regulated industry.
- 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).
- 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.
- Ability to physically perform the functions of balancing, stooping, kneeling, crouching, reaching, standing, walking, pushing, pulling, lifting, grasping, talking, hearing, and repetitive motions.
- Possess visual acuity to document company records.
- Ability to lift 50 pounds.
Who we are ...
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world's biggest investors in Research & Development.
What we look for ...
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
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We are an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of its manifestations.
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Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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.
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