Specialist, Engineering Deviation Management (Hybrid)

Job Description

The function of this position is to provide engineering technical support to the manufacture of liquid vaccines. The role encompasses technical services support primarily in the area of Deviation Management. Scope will cover bulk vaccine manufacturing and may span across multiple areas of focus.

Position Responsibilities:

• The role will include authoring process deviations, performing human performance consultations, generation and authoring of CAPAs, implementation of CAPAs (where applicable), deviation trending and reporting. Participate in real time investigations with the goal of fully understanding root cause and product impact.

• Collaborate with Operations, Automation, EM&U and Quality to restart a drug substance manufacturing facility from a shutdown state. This includes proactive identification of best practices and implementation of HuP improvements.

• Where applicable, complete investigational test protocols to determine root cause, product impact, event scope, etc.

• Complete projects to improve the performance of our processes, including projects aimed at improving Right-First-Time performance or preventing/reducing deviations, and value capture projects that seek to improve yield, reduce cost, or lower our processing cycle times

• Manage project timelines to ensure key compliance and customer due dates are met; escalating any potential misses and develop remediation plans when possible

• Support requests for regulatory inspections related to process overviews, investigations, projects and validation.

• Support team safety, environmental, and compliance objectives.

• Collaborate effectively with the area Managers, Operators/Technicians, support groups (Mechanical Services, Trades, Automation, Technology), Quality, and Planning.

• Actively use and champion the use of Lean Six Sigma (LSS) and Production System (MPS) tools, both in problem solving and day-to-day operational activities.

• Author updates to Master Batch Records (production process descriptions) and SOPs (Standard Operating Procedures).

Education Minimum Requirement:

• B.S. in Mechanical or Chemical Engineering Degree or other Engineering/Science Degree

Required Experience and Skills:

• Engineering, mechanical or science educational background 

• Minimum of 2-year post-Bachelor’s degree experience in support of Production, Process Engineering, Validation, Technical Services or related experience  

• Demonstrated ability to work both independently and as a part of a team.

• Demonstrated leadership and teamwork skills, excellent analytical abilities, established written and verbal communication skills

Preferred Experience and Skills:

• Hands-on technical services experience in drug substance vaccine manufacturing

• Experience with troubleshooting biotech equipment and closed system processing. 

• Experience with SAP, PI, DeltaV, ProCal

• Ability to read Piping and Instrumentation Diagrams

• LSS/MPS certification/experience. 

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.

VETJOBS

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”.

Search 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:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

N/A

Requisition ID:R288881