Senior Specialist, Engineering - External Manufacturing Vaccine Technical Operations
Senior Specialist, Engineering - External Manufacturing Vaccine Technical Operations
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Job Description
Job Description
Position Description:
The External Manufacturing Vaccine Drug Product Technical Operations (ExM Vaccine DP TO) organization is seeking a highly motivated individual for a Sr. Specialist Engineering Vaccine DP TO is accountable for technology transfers and commercial production of sterile drug product at our Companys External Partners (EPs). This person will have the opportunity to participate and lead activities in all these areas.
Responsibilities include:
Work with External Partners to achieve business goals and to establish a common culture that benefits both our company External Partners and patients
Responsible for technical activities for the commercial manufacturing process at the External Partner which includes authorship of change control management of process improvement projects statistical analysis of process performance and investigation of atypical events
Responsible for technical transfer activities as applicable through authorship and/or review of required GMP documentation (Master Batch Records change control protocols reports qualifications etc.) and regulatory filings.
Provide on-site coverage at External Partner in support of Commercial and / or Tech Transfer Person In Plant Activities
Translate understanding of GMP requirements and current regulations and develop standardized work to meet these requirements by partnering with Operations Quality and External Partners
Ensure that External Partners are inspection ready for all routine inspections and / or inspections related to new product introductions or transfers in concert with Operations Quality and Regulatory
Responsible for participation in creating sharing and adopting best practices and business process strategies
Position Qualifications:
Education Minimum Requirement:
Bachelors degree in chemical/Biochemical Engineering Pharmaceutical Science or Chemistry/Biology or other related science or engineering field.
Required Experience and Skills:
Minimum of 4 years post-bachelors degree experience in a GMP functional area or support of a GMP functional area such as Operations Technical Operations Technology Engineering and/or Maintenance
Travel will be a requirement of this position at up to 50%
Strong communication and teamwork skills
Preferred Experience and Skills:
Experience in sterile / aseptic manufacturing
Demonstrated ability to independently manage projects/work to schedule/deadlines
Statistics experience
Experience in deviation management and/or change control and/or equipment support and/or project management.
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.
The salary range for this role is
$114700.00 - $180500.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive if applicable.
We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
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:
50%Flexible Work Arrangements:
RemoteShift:
1st - DayValid Driving License:
NoHazardous Material(s):
n/aRequired Skills:
Applied Engineering Business Management Business Performance Management Business Processes Chemical Biology Enterprise Operations GMP Compliance Management Process Manufacturing Engineering Manufacturing Processes Mechatronics New Product Introduction Process Process Improvement Management Process Improvement Projects Project ManagementPreferred Skills:
Automation Engineering Biological Engineering Business Operations Business Process Development Business Process Improvements Chemical Engineering Communication Documentations Engineering Technology Equipment Maintenance Lean Process Improvements Maintenance Management Maintenance Plans Manufacturing Operations Management Partnership Development Plant Care Policy Development Process Improvements Quality Control Systems Quality Management Regulatory Compliance Regulatory Documents Teamwork Waterfall ModelJob Posting End Date:
07/17/2025*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.
Required Experience:
Senior IC
Employment Type
Full-Time
