Senior Specialist, Engineering

Job Description

The Formulation, Laboratory, and Experimentation (FLEx) Center located in Rahway, New Jersey includes a state-of-the-art sterile drug product cGMP clinical supply manufacturing facility known as FLEx Sterile that is currently in operational startup phase.  The FLEx Sterile facility will play a major role in the long-term success of delivering our clinical pipeline to patients across the globe throughout a range of product modalities which includes sterile small molecule, biologics, vaccines, antibody drug conjugates (ADCs), in addition to others.    

The Senior Specialist, Engineering will serve as a business representative in the FLEx Sterile Expansion Project which is currently in Conceptual Design Phase (also known as Front End Loading Phase II, FEL-2).  The FLEx Sterile Expansion Project is intended to more than double the expected capacity of the existing FLEx Sterile Facility by way of bringing on a second clinical filling/lyophilization suite, formulation suite, as well as sterile supply suite in addition to various supporting infrastructure and utilities.

This is an exciting opportunity to partner with our Company's Research Laboratories (M formulation scientists, Global Engineering Solutions (GES) engineers, Safety and Quality representatives, Digital and IT, equipment vendors, and other team members to drive the design aspects, risk assessments, strategic planning, execution, facility startup and operational readiness of the FLEx Sterile Expansion Project. This individual will collaborate closely across a wide range of stakeholders and gain depth and breadth from a multitude of topics spanning equipment and facility design, financial and capital management, team building, process sciences, operational excellence, technical writing, and networking. 

The role is based in at our Corporate Headquarters in Rahway, New Jersey and reports to the FLEx Sterile Expansion Business Lead within Pharmaceutical Operations and Clinical Supply. 

Education Minimum Requirements: 

• Bachelor’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 4 years relevant experience

• Master’s degree with a minimum of 2 years relevant experience

Required Experience and Skills:

• Familiarity with United States and European Union cGMP and Safety compliance regulations.

• Ability to prepare Risk Assessments, Standard Operating Procedures (SOP) and current GXP documents.

• Effective interpersonal and communication skills, both verbal and written.

• Excellent organizational skills to multi-task.

• Desire and willingness to learn, contribute and lead.

• Experience in drug product aseptic processing, equipment and aseptic technique.

• Track-record of independent problem-solving.

Preferred Experience and Skills:

• Ability to convert new drug product attributes and process needs to an executable series of steps and procedures to enable acceptable product manufacture.

• Experience with large scale capital projects.

• Experience in leading and supporting quality investigations and change management.

• Experience with sterile drug product GMP facility startup.

• Experience with Commissioning, Qualification and Validation.

• Knowledge of Investigational drug regulatory requirements.

• Understanding of Clinical Supply Chain Operations.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).  Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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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, generally Tuesday, Wednesday and either Monday or 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”.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected US salary range:

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

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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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