The Specialist, Operations supports manufacturing operations in the Live Virus Vaccines organization. This high impact role in our Company Manufacturing assures that products manufactured comply with cGMPs, operating procedures and other applicable regulations. This role focuses on shop floor compliance and implementation of lean manufacturing initiatives aligned with department goals. Position Responsibilities:Supports the managers in the direct processing of materials to ensure attainment of b... more details
Job Description
The Specialist, Operations supports manufacturing operations in the Live Virus Vaccines organization. This high impact role in our Company Manufacturing assures that products manufactured comply with cGMPs, operating procedures and other applicable regulations. This role focuses on shop floor compliance and implementation of lean manufacturing initiatives aligned with department goals.
Position Responsibilities:
Supports the managers in the direct processing of materials to ensure attainment of business results
Develops an in-depth knowledge of the equipment and process
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
Compliance:
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
Business Expertise:
Perform 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
Participate in the design and implementation of training and development programs and 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/implements appropriate and effective corrective and/or preventative actions (CAPAs) to prevent reoccurrence of deviations and ensure they improve the Right First Time metrics
Problem Solving | Decision Making:
Identifies and solves a range of problems in straightforward situations; analyzes possible solutions and assesses each using standard procedures
Makes 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 two (2) years of relevant experience in manufacturing
OR
AND
Required Experience and Skills:
Familiarity with cGMPs in pharmaceutical industry
Demonstrates strong problem-solving skills and a hands-on approach to problem solving
Ability to work independently
Preferred Experience and Skills:
Formal problem-solving techniques, such as root cause analysis (RCA), failure mode effects analysis (FMEA) and/or Lean Six Sigma Tools
Manufacturing plant experience in operational capacity
Working in a Union environment
SAP or other Enterprise Software
Knowledge of CFR regulations
Shift and Hours:
2nd shift M-F - 4pm - 12am
Willingness to work off-shift and weekends to support production
Rotation of weekend coverage
#MSJR
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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Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Not Applicable
Shift:
2nd - Evening
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
07/5/2024
*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.