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Specialist, Purification Operations

4 months ago

Durham, North Carolina, United States Merck Full time

Job Description
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.
The Maurice R. Hilleman Center for Vaccine Manufacturing is located in Durham, NC. Due to the importance of this facility in our Company Vaccine Manufacturing network, the facility has seen rapid growth in production volumes and new employees over the last several years; currently Durham employs 1,000+ people.
This role as an Operations Specialist will be an energetic individual with strong interpersonal, leadership, and collaboration skills responsible for supporting Operational Readiness projects and initiatives for a new manufacturing facility. This role will contribute to the overall performance and results of a E2E drug substance department. Off-shift and weekend coverage will be required based on business unit needs during start up and operations, and specific assignments.
Responsibilities may include but are not limited to;

  • Partnering with the Operations management team to create and execute strategies that support design, development, delivery and evaluation of projects related to steady-state production and/or continual process improvement.
  • Authoring and reviewing documents and SOPs.
  • Author deviations and works to coordinate, develop and implement Corrective Actions/Preventive Actions (CAPAs).
  • Ensuring visibility and accuracy of the project schedule and update dashboards accordingly to highlight the project status of critical milestones.
  • Ability to effectively support, upskill and mentor new employees
  • Analyzing and implementing initiatives that will help to increase overall success within the department.
  • Effectively using metrics and measurement to ensure that projects and initiatives result in desired outcomes.
  • Ability to prioritize workload under guidance from management.


Education Minimum Requirement:

  • High School Diploma AND at least Five (5) years in a manufacturing, technical, support, or Military role. OR
  • Bachelor's degree in a technical field AND at least Three (3) years in a manufacturing, technical, support, or Military role.
  • Bachelor's degree and at least One (1) year of experience in a direct GMP, biotechnology, manufacturing setting.


Required Experience and Skills:

  • Experience working in a GMP environment
  • Demonstrated written and verbal communications skills
  • Ability to foster a collaborative work environment
  • Demonstrated interpersonal, technical aptitude, and problem-solving skills
  • Strong team skills, including the ability to coach/develop work teams, provide training, motivate/empower others, and resolve conflict
  • Must be flexible and able to manage multiple priorities


Preferred Experience and Skills:

  • Understanding of Lean Six-Sigma methodologies
  • Experience with shop-floor cGMP manufacturing and related systems (i.e. SAP)
  • Familiarity with pharmaceutical regulatory requirements
  • Project management and data analysis skills
  • Technical writing experience
  • Experience with facility, equipment and/or process start up activities in a cGMP environment
  • Demonstrated ability to work independently
  • Production planning / scheduling experience


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.
Current Employees apply HERE
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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".
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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.
Employee Status:
Regular
Relocation:
Domestic
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Not Applicable
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
N/A
Job Posting End Date:
05/30/2024
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Job Posting End Date:05/30/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID:R294919