Spclst, Operations
Spclst, Operations
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Job Description
Job Description
Job Description:
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69000 employees operating in more than 140 countries we offer state of the art laboratories manufacturing 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 worlds biggest investors in Research & Development.
We are seeking individuals with strong scientific and technical skills to contribute to the design development and manufacturing of sterile products making accessible our companys next generation of Vaccines and Biologics. To this end we strive to create an environment of mutual respect encouragement and teamwork. As part of our team youll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
We have an exciting opportunity for a Specialist to join the operations team supporting a capital project critical to Human Health at our facilities in Durham North Carolina. This new facility will include end-to-end processing of both drug substance and drug product including product inspection warehouse utilities and quality control laboratories.
The Specialist Operations will be responsible for providing support to the manufacturing area as part of the Operations team.
This is a full-time position working Monday through Friday dayshift (normally 8:00am-4:30pm)
Applicant must complete and be medically cleared for BCG medical clearance requirements: questionnaire blood test chest x-ray
Position Responsibilities:
This role reports to an Operations Associate Director and supports the product transfer for a new facility in Durham NC within Drug Substance Drug Product and/or supporting areas.
Support and execute to approach for production team as part of tech transfer and modernization for process
Collaborate with broad partners and stakeholders across MPS GES and across site for information
Independently manage project assignments escalate potential delays and develop remediation plans when applicable
Collaborating across diverse teams
Creating strong safety culture
Contributing to the manufacturing team and support for the facility
Leading routine process support projects and improvement activities
Serving as subject matter expert on the process for daily work and projects understand full process requirements such as safety compliance process
Providing guidance for daily production support projects deviations and changes
Required Experience and Skills:
Bachelors degree in an Engineering or Science related field with minimum of 2 years post-degree experience inmanufacturing operations pharma biotech or vaccines work environment
Communication leadership and teamwork skills
Preferred Experience and Skills:
cGMP experience in a sterile bulk biologics or pharmaceutical environment operations technical services supply chain and/or quality operations
Experience with aseptic processing operations such as bulk production formulation vial filling and lyophilization and/or supporting clean utilities
Demonstrated ability to work in fast-paced complex environments and escalate appropriately
Flexibility and ability to manage multiple priorities
Demonstrates interpersonal technical aptitude and problem-solving skills
Experience using Lean Six Sigma Operational Excellence tools
VETJOBS #EBRG
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
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.
As an Equal Employment Opportunity Employer we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race color age religion sex sexual orientation gender identity national origin protected veteran status disability status or other applicable legally protected a federal contractor we comply with all affirmative action requirements for protected veterans and individuals with disabilities. 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 together talented and committed people with diverse experiences perspectives skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas broad experiences backgrounds and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one anothers thinking and approach problems collectively.
Learn more about your rights including under California Colorado and other US State Acts
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 Monday - 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 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.
San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance
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.
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
Not ApplicableShift:
1st - DayValid Driving License:
NoHazardous Material(s):
N/ARequired Skills:
Adaptability Biopharmaceutical Industry cGMP Compliance Communication Computer Literacy Data Analysis Environmental Health and Safety (EHS) Management Lean Manufacturing Tools Management Process Operational Excellence Process Optimization Process Troubleshooting Production Operations Production Support Project Management Regulatory Compliance Teamwork Training and DevelopmentPreferred Skills:
Leadership Materials Management Process ImprovementsJob Posting End Date:
05/31/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Employment Type
Full-Time
