Senior Specialist, Engineering
Senior Specialist, Engineering
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Job Description
Responsibilities
- Serve as a leader in the Formulation Laboratory and Experimentation (FLEx) Sterile GMP Clinical Manufacturing facility.
- Contribute to equipment and facility design system commissioning/ qualification regulatory certification as well as other workstreams critical activities to enable facility startup and operational readiness.
- Collaborate closely with the formulation scientists engineers quality representatives and other team members to ensure the quality of the clinical supplies the scientific rigor of the processes and ultimately to enable the flexibility and speed of the companys pipeline.
- Support the formulation process development and scaleup activities quality investigations and change management and author GMP standard operating procedures and protocols in support of facility operations.
Education Minimum Requirement:
- Masters degree in Chemical Engineering Chemistry Industrial Engineering Pharmaceutical Sciences or closely related scientific field with 2 years relevant experience OR a Bachelors degree in Chemical Engineering Chemistry Industrial Engineering Pharmaceutical Sciences or closely related scientific field with a minimum of 5 years relevant experience.
Required Experience and Skills:
- Experience in leading and supporting quality investigations and change management and experience with quality systems also required.
- Must have knowledge and experience of drug product aseptic processing equipment and sterile technique; and familiarity with United States and European Union Good Manufacturing Practice (GMP) and Safety compliance regulations.
- Must possess ability to convert new drug product attributes and process needs to an executable series of steps and procedures to enable acceptable product manufacture.
- Must possess the ability to prepare Standard Operating Procedures (SOP) and other documents in accordance with current good practice guidelines and regulations (GxP).
- Must have effective interpersonal and communication skills both verbal and written; and excellent organizational skills.
- Must demonstrate a desire and willingness to learn contribute and lead; and a trackrecord of independent problemsolving.
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
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.
U.S. Hybrid Work Model
Effective September 5 2023 employees in officebased positions in the U.S. will be working a Hybrid work consisting of three total days onsite per week Monday Thursday although the specific days may vary by site or organization with Friday designated as a remoteworking day unless business critical tasks require an onsite Hybrid work model does not apply to and daily inperson attendance is required for fieldbased positions; facilitybased manufacturingbased or researchbased positions where the work to be performed is located at a Company site; positions covered by a collectivebargaining 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 preexisting 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:
No Travel RequiredFlexible Work Arrangements:
Not ApplicableShift:
1st DayValid Driving License:
NoHazardous Material(s):
N/AJob Posting End Date:
07/8/2025*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
