Senior Specialist, Engineering

Job title: Senior Specialist, Engineering in Rahway, NJ at MSD
Company: MSD
Job description: Job DescriptionResponsibilities

• 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 company’s pipeline.
• Support the formulation, process development, and scale-up activities, quality investigations and change management, and author GMP standard operating procedures and protocols in support of facility operations.

Education Minimum Requirement:

• Master’s degree in Chemical Engineering, Chemistry, Industrial Engineering, Pharmaceutical Sciences or closely related scientific field with 2 years relevant experience OR a Bachelor’s 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 track-record of independent problem-solving.

Current Employees applyCurrent Contingent Workers applyUS 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 characteristics. As 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 another’s thinking and approach problems collectively.U.S. Hybrid Work ModelEffective 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 presence.This 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 OrdinanceLos 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 OrdinanceSearch 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: 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 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.
Expected salary:
Location: Rahway, NJ
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