Key vaccine product franchises are experiencing significant growth requiring staffing to support key initiatives. The Specialist, Technical Services Project Engineer in the BioBacterial Manufacturing End-to-End is responsible for technical support and execution of projects in the commercial manufacturing area while actively supporting, participating in, and embracing an empowered team culture. In this role, the Project Engineer will work as an individual contributor, may act as a team or project lead and lead work of others as required, as well as contribute to the performance and results of a department. Additionally, this individual will provide technical guidance and anticipate and interpret client and/or customer needs to identify and implement solutions.
Establish and manage project schedules and timelines.
Develop and execute Change Control inclusive of change definition, quality risk assessments, impact assessments, task execution, implementation, and support of associated regulatory filings.
Determine project resource requirements and works with stakeholders to gain support needed from subject matter experts. Stakeholders may include Operations, Quality, Regulatory, Analytical and Process Development functions.
Responsible for stakeholder engagement, communication, and risk escalation.
Author/ update technical and manufacturing documents necessary for process design/ definition, engineering studies, process demonstrations, and validation.
Design/conduct experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale.
Examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.
Develop and assure consistent application of standardized work, engineering, and process tools.
Provide technical support to manufacturing for complex problems and issues.
Work as a team member on complete manufacturing investigations, process improvement and/or validation projects.
Education Minimum Requirement:
Bachelor's Degree in Engineering or Science
Required Experience and Skills:
Minimum of two (2) years of work experience in the biological/ pharmaceutical/chemical manufacturing industry (can be obtained through a combination of post-graduate education and work related experience).
Experience in biologics, vaccine, or bulk sterile manufacturing facilities in a process or validation support role.
Minimum of six (6) months work experience with cGMPs, Change Control, CFR, and other appropriate regulations to vaccine manufacturing.
Preferred Experience and Skills:
Strong understanding of Change Control and project management
Demonstrated ability to work both independently and as a part of a team
Strong technical problem-solving abilities
Demonstrated effective written and verbal communication skills
Strong collaboration and leadership skills
Familiarity or experience with aseptic Vaccine Manufacturing Operations
Experience with introduction of process changes to a licensed process
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”.
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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.
Flexible Work Arrangements:Hybrid
Shift:1st - Day
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