Senior Project Engineer

Job Description

This Engineer Senior Specialist (P3) position will provide compliance project engineering leadership for the Rahway, NJ FLEx (Formulation, Laboratory & Experimentation) center, including the RY119 Development center and the WP Sterile Liquids pilot plant under the remit of Our Company's Research Labs Pharmaceutical Sciences (Pharm Sci), Pharmaceutical Operations & Clinical Supplies (Pharm Ops) organization.

The SLP and FLEx facility supports the formulation and filling of clinical, stability, and developmental supplies for Oral Solid Dosage (OSD) and Inhalation products, vaccines and sterile forms, including critical program needs related to new products undergoing process development, new products undergoing scale-up, launch and transfer to the supply network and existing commercial products undergoing process optimization.

Primary responsibility will be to lead execution of project management (capital and expense) and administration in support of new equipment purchases and existing equipment modifications.  This will include working with the scientist and formulators, original equipment manufacturers (OEMs) and project engineering groups (GES) to specify, design, build and install the required equipment to increase capability for Pharm Science or implementation of technologies to existing equipment or facilities, to meet potent handling and Industrial Hygiene (IH) compliance requirements.

Other responsibilities will include support of departmental (Pharm Sci) Capital Management, Engineering initiatives, Safety Compliance initiatives and metrics, assisting in safety investigations and root-cause analysis (RCA), as well as support of various departmental program actions: Process Safety Management (PSM), IH Compliance plans, etc., that typically require actions on an annual basis.

The candidate will provide administrative oversight support in terms of SAP Capital Project Administration and interact with Enablon, E-Val and QMS.  The candidate will support communication and partnering efforts with Global Engineering Solutions (GES), Global Safety & Environmental (GSE), as well as at-site partner groups (GWES, Sodexo, etc.).    

Minimum education required:

Bachelor's Degree in Engineering or Science plus a minimum of 5 years of Drug Product or related experience.

Required experience and skills:

• Strong familiarity with Quality, cGMP, Safety & Environmental Policies and Procedures.

• Strong familiarity with Capital Project management & execution. 

• Must have demonstrated experience executing capital projects. 

• Ability to flow to the work across projects and support multiple projects simultaneously.

• Effective organizational skills. 

• Effective communication

• Strong computer skills

Preferred Experience and Skills: 

• Experience with our company's GES Engineering Standards & Guidelines

• Experience with our company's GSE Safety & Environmental Standards and Guidelines

• SAP Training and skills - Project Manager (PM) role, SAP Plant Maintenance

• Experience with ProCal as a Computerized Calibration Maintenance System (CCMS).

• Familiarity with Planning and Scheduling practices as well as business/financial practices. 

• The candidate should be able to work independently and lead or facilitate tasks successfully.

#eligibleforERP

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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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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