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 are seeking a growth and improvement minded Manufacturing Operations Specialist that can help drive our Strategic Operating Priorities.
Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs
Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)
Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape
Diverse Talent | We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world
Values and Standards | Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success – They are a Competitive Advantage for Us
The Manufacturing Operations Specialist supports manufacturing operations in the BTM organization. This high impact role in our Company assures that products manufactured comply with cGMPs, operating procedures and other applicable regulations and focuses on continuous improvement, shop floor compliance and implementation of lean manufacturing initiatives aligned with department goals.
Additional Key Responsibilities
Support shop-floor managers in the direct processing of materials to meet safety, quality, compliance, and business goals.
Develop and maintain a thorough understanding of the production process and equipment.
Builds knowledge of the company, process, clients and/or customers.
Applies team effectiveness skills, listening and integrating diverse perspectives from across the workgroup.
Manage conflict and effect resolution of technical and personal challenges using standard procedures is key as is openness to change and the ability to effect positive change.
Contributes and adds value to the achievement of team goals.
Develops tools to assist with shop floor execution and operability of manufacturing processes.
Ensure compliance with safety and environmental practices, cGMPs and SOPs in the work area.
Demonstrate integrity, credibility, and flexibility in their daily performance so as to motivate others to do the same.
Conduct a thorough review of batch records and related GMP documentation, identifying and resolving discrepancies in a timely manner and implementing corrective actions to improve the batch record execution/review process.
Work with subject matter experts (SME’s) to provide/track necessary training for operator qualification as assigned and Participate in the design and implementation of training and development programs/training materials.
Foster a collaborative relationship with manufacturing floor personnel focused on high quality investigations, meaningful corrective actions and reducing the deviation generation rate.
Determines and implements appropriate and effective corrective and/or preventative actions (CAPAs) to prevent reoccurrence of deviations and ensure they improve the Right First Time metrics.
Works with and leads cross-functional team through process improvement projects and problem solving to achieve business goals.
Identifies and solves a range of problems in straightforward situations; analyzes possible solutions and assesses each using 8-step problem solving or other MPS methodology.
Responds to process delays real-time, identifies root-cause, develops countermeasures, and leads countermeasure execution.
Make decisions that are guided by site policies and procedures.
Collaborates with supporting departments such as Quality, Tech Ops and Maintenance to solve problems in an efficient and compliant manner.
Consults with manager on more complex decisions and issues that impact other departments.
Project & Resource Management
Accountable for contribution to project team or sub-team, may manage/led a small project team.
Collaborates with team members in the identification and implementation of continuous improvement initiatives and action plans.
Supports activities in the areas of cost containment, efficiency, productivity, energy conservation, waste minimization, operational excellence, and lean practices.
Aware of costs and assists in controlling costs related to own work.
Minimum Required Education, Experience and Skills:
Bachelor’s degree or higher, preferably in Science, Engineering, Business Administration, or another technical field with one (1) years of relevant experience in manufacturing
High School Diploma/GED with four (4) years of relevant experience in manufacturing or military service
Willing and able to work off-shifts and weekends as needed
Required Experience | Knowledge | Skills:
Work independently and as a Team member with Integrity | Precision | Accomplishment | Principled Ambition | Respect
Strong leadership capability, problem-solving skills and a direct approach to problem solving.
Proficient computer capabilities working in Microsoft Excel, Word, PowerPoint and OneNote
Collaborate with cross-functional group to achieve business and project goals.
Preferred Experience and Skills
One to two years cGMP in a sterile, bulk or finished pharmaceutical environment.
Manufacturing plant experience in operational capacity
Writing and updating SOPs, Logbooks and other GMP documentation
Working in a Union environment
Position will be Tuesday - Saturday, 1st Shift (7:30 AM - 4:30 PM)
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.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
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Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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.
Travel Requirements:No Travel Required
Flexible Work Arrangements:Not Specified
Shift:1st - Day
Valid Driving License:Yes
Hazardous Material(s):acid and bases