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.
We have an exciting opportunity for a Manufacturing Support Specialist to join Organon Teknika, a subsidiary of our company, within our Manufacturing Division, supporting the BCG manufacturing facility in Durham, NC.
In this role, the candidate will serve on the BCG Manufacturing Support team working with shop floor production personnel and interfacing with Technical Support and Quality Operations. Furthermore, the candidate must be able to work efficiently in a fast-paced environment and be hands-on when called for by the situation. Thisposition requires one to collaborate across boundaries, build personnel capabilities/skillsets, give people a voice and implement continuous improvements that sometimes challenge the status quo. Off-shift or weekend coverage may be required occasionally, based on project-specific assignments.
Primary Responsibilities and Activities include but are not limited to the following:
- Implement continuous improvement projects which may require change controls or have a regulatory impact.
- Actively participate on cross-functional teams to advance project goals and deliverables.
- Maintain alignment and partner with Operations, Technical Operations, Quality, and Automation on different projects and initiatives.
- Author and update GMP documentation including but not limited to SOPs and batch records.
- Serve as the Operations Reviewer for batch records and logbooks when the Primary Operations Reviewer is out of the office. Review batch records and logbooks for errors and collaborate with production personnel to correct such errors and provide clarification as needed.
- Support the Data Integrity (DI) Champion with the implementation of DI CAPAS and initiatives.
- Support the MPS Lead to deploy MPS Strategy on the production floor by implementing 5S, Standardized Work, performing cycle time studies.
- Participate in Quality Risk Assessments.
- Assist with troubleshooting and effectively resolving problems. Develop and implement corrective actions to unplanned (atypical) manufacturing events to ensure a consistent and reliable supply and prevent a recurrence. The successful candidate should be able to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) to best understand and resolve it at the root cause.
- Use standard systems including MS Word, Excel, PowerPoint, Outlook, SAP and various company and industry-specific software.
- Support real-time problem-solving techniques, such as root cause analysis and/or Lean Six Sigma tools
- Bachelor degree in an Engineering or Science related field with minimum 2 years post-bachelors degree experience in GMP manufacturing and/or technical support of GMP
- OR 1 year of the described experienced plus a Master's degree in an Engineering or Science related field
- OR 4 years of the desired experience
- Experience with aseptic processing operations such as cell culture, filling, and lyophilization.
- Familiarity with process risk assessment tools, Quality by Design principles, and Lean/Six Sigma methodologies
Required Experience and Skills:
- Experience in pharmaceutical manufacturing within a cGMP environment
- Experience authoring SOPs within a cGMP context
- Outstanding communication (written & presentation) skills
- Demonstrated effective written and verbal communication skills
- Demonstrated ability to work both independently and as a part of a team.
Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that's committed to delivering a high quality, reliable supply to customers and patients on time, every time.
Who we are ...
Merck & Co., Inc., Kenilworth, New Jersey, USA is known as "Merck" in the United States, Canada & Puerto Rico. We are known as "MSD" in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
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.
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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 Acquisiti
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