Sr. Spclst, Engineering (2nd Shift) Onsite

Job Description

Job Description:

The Formulation Laboratory and Experimentation (FLEx) Center in Rahway New Jersey features a cutting-edge sterile drug product cGMP clinical supply manufacturing facility known as FLEx Sterile. The FLEx Sterile facility is poised to play a pivotal role in the long-term success of delivering our clinical pipeline to patients worldwide encompassing a diverse range of product modalities including sterile small molecules biologics vaccines and antibody-drug conjugates (ADCs). The FLEx organization has a mission to enable development of our Companys pipeline products with speed agility and rigor. This mission will be accomplished by: 1) Enabling robust formulation and process development with flexible physical and digital infrastructure; 2) Delivering compliant high quality clinical supplies; 3) Developing talents with a new operating model and promoting a growth mindset. As the facility nears completion of its Process Simulation execution this presents an exciting opportunity for individuals eager to learn demonstrate themselves and grow with a rapidly expanding team.

The FLEx organization is seeking a highly motivated individual to serve the role of Senior Specialist Technical Operations Engineer reporting to the Technical Operations Lead. The successful candidate will support routine operations through timely troubleshooting of production equipment issues establishment of new processes and implementation of continuous improvement projects with goals to reduce operation cycle time errors and costs. This individual will collaborate closely with the Production New Product Introduction Facilities Equipment Automation and Quality teams to ensure compliant right first time execution and timely delivery of business goals. The role is on-site based in Rahway NJ and will support our second shift operations which operate from 3:30 PM EST to 12AM EST. Due to the nature of second shift operations flexibility and overtime may be required occasionally to coordinate with personnel from first shift. Occasional weekend work may also be required to support operations.

Education Minimum Requirements:

• BS or MS in Chemical Engineering Mechanical Engineering Biomedical Engineering or related engineering field with a minimum of 5 years of relevant experience.

Required Experience and Skills:

• Subject Matter Expertise in various sterile processing equipment such as automated filling lines lyophilizers autoclaves part washers isolators and etc.

• Knowledge of automation systems such as PLC DCS and MES.

• Knowledge of Drug Product processing aseptic processing techniques.

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

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

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

• Possesses effective project management skills to drive process improvement. Able to communicate clearly business/compliance driver develop and manage project plan to meet deliverables and escalate issues with meeting objectives to avoid schedule impact.

• Strong technical aptitude and critical thinking skills to effectively troubleshoot and resolve issues on the production floor.

• Possess and leverages strong working knowledge of theories practices and procedures to train others efficiently. Applies knowledge to improve processes.

• Familiarity with common Drug Product processing unit operations such as mixing filtration temperature control and etc.

• Lean Six Sigma Green Belt certification.

• Effective interpersonal and communication skills both verbal and written. Able to cultivate and leverage working relationships with stakeholders within department as well as across the organization.

• Excellent organizational skills to multi-task.

• Desire and willingness to learn contribute and lead.

• Track-record of independent problem-solving.

Preferred Experience and Skills:

• Experience with Commissioning Qualification and Validation of equipment.

• Understanding of ISA88 and ISA95 principles.

• Knowledge of Investigational drug regulatory requirements.

• Understanding of Clinical Supply Chain Operations.

• Lean Six Sigma Black Belt certification.

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Required Skills:

Preferred Skills:

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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 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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Relocation:

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