Commissioning and Qualification Engineer, Oral Solid Dosage

Job Description

The Engineering Specialist in our companys Research Labs (Pharm Ops Engineering) leads Commissioning Qualification and Validation (CQV) activities and provides engineering support for process equipment and utilities used to manufacture oral solid dosage (OSD) forms.

Supporting the FLEx (Formulation Laboratory & Experimentation) Center in Rahway NJ the candidate authors and executes CQV protocols (IQ/OQ/PQ) and ensures cGMP compliance and adherence to our companys Quality Manual for new and modified equipment systems and critical utilities supporting capital projects and ongoing operations.

Candidates should demonstrate effective organizational and communication skills strong computer proficiency and the ability to flexibly support both Quality and Facilities/Equipment work are essential with preferred experience in Kneat (paperless validation) computerized maintenance and calibration management systems (CMMS and CCMS) and the capability to work independently while leading or facilitating tasks.

The FLEx Center operates on a two-shift schedule and may require coverage beyond standard business hours. Candidates may be required to work extended 1st shift hours and provide on-call support as needed based on demands.

Education Minimum Requirement:

• Bachelors degree in engineering or science and 2 years of commissioning/qualification experience supporting OSD forms.

Required Experience and Skills

• Commissioning and qualification experience including change controls and periodic reviews.

• Familiarity with OSD process equipment and operations (granulation milling blending drying tablet compression and coating encapsulation).

• Experience with GMP Good Documentation Practices (GDocP) and pharmaceutical manufacturing operations.

• Familiarity with CMMS/CCMS and validation tools (e.g. Kneat).

• Strong organizational time-management and communication skills (oral and written); ability to prioritize multiple tasks.

• Able to work independently and collaboratively demonstrates initiative to support team needs.

• Proficient with standard business software.

Primary Activities

• Develop execute and maintain CQV documentation and testing (IQ/OQ/PQ).

• Participate in and support continuous improvement activities within the oral solid dosage facility

• Ensure compliance with cGMP the Quality Manual SOPs and applicable guidelines.

• Support continuous improvement initiatives within the OSD facility.

• Support investigations and implement corrective and preventive actions (CAPA)

• Support audits regulatory inspections and facility tours.

Required Skills:

Preferred Skills:

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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

This 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

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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.

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