Specialist, Operations - West Point, United States - Merck Sharp & Dohme
Description
The West Point, PA campus is our Company's largest vaccine manufacturing facility with more than 2000 employees.This facility manufactures bulk and/or final dosage forms for all our Company vaccine products and is growing to meet the vaccine demands of the future.
The Building 50 Live Virus Vaccine Filling Facility Project team is seeking a highly motivated individual to fill an open position to lead the start-up of a new vaccine filling & lyophilization facility at the West Point site.
Facility start-up will include design, commissioning, equipment qualification and live virus vaccine drug product process demonstration in support of facility licensure.
The Specialist, Operations will be an energetic team member with strong collaboration skills responsible for partnering with multiple functions to execute facility design, construction, startup and operational readiness.
Upon completion of the facility design & construction this is targeted for promotion to a Manager role directing the operators and the daily execution in the facility.
Primary Responsibilities:
Reporting to the Associate Director of Operations or Operations Manager, the Operations Specialist primary responsibility will be to help facilitate day to day production and support of operations.
This position will require off-shift or weekend coverage based on business unit needs and specific assignments. The Operations Specialist has the opportunity to develop into a manager with a rapidly growing pharmaceutical manufacturer
- Assists Operations manager in execution of duties
- Delivers operational improvements on key business projects, including updating weekly metrics and deliverables
- Promote a culture of continuous improvement and challenging the status quo
- Complete documentation of deviation events
- Complete production batch record review (post
- Production)
- Coach and provide oversight on shop floor to identity potential issues before they arise and prevent deviations
- Ownership of the Leader standardized work process which prioritizes resolution of issues from the shop floor and drives resolution through 8step problem Solving and other Lean tools.
- Collaborate with peers on global teams to ensure a positive learning organization, alignment of strategy and sharing best practices
- Mentor others on effective communication and active listening techniques to fully understand needs and expectations
- Assist operations team and shop floor to with defining the requirements of the electronic batch record and successful execution
Minimum Required Education, Experience and Skills:
- Bachelor's degree or higher, preferably in Science, Engineering, Business Administration, or another technical field
OR
- High School Diploma/GED with four (4) years of relevant experience in manufacturing or military service
AND
- Willing and able to work offshifts and weekends as needed
Preferred Experience and Skills:
- Demonstrated record of successfully working in team environments and influencing people with a broad range of skills and experience.
- Performance mindset to drive and influence behaviors on the floor
- Selfmotivation, ambition, resilience, and confidence in taking risk
- Lean, Six Sigma problem solving skills coupled with a continuous improvement mindset
- Ability to prioritize, focus on and obtain business results
- Excellent communication and organizational skills
- Technical writing experience related to procedures and investigations
- SAP, MES and DeltaV experience is an advantage
Shifts:
1st Shift Tue-Sat
2nd Shift Sun-Thur
3rd Shift Tue-Sat
Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide.
Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that's devoted to delivering a high quality, reliable supply to customers and patients on time, every time.
NOTICE FOR INTERNAL APPLICANTS
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.
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**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
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