Senior Specialist

Job Description

We currently have a Senior Specialist of Engineering position available in Technical Operations with process subject matter expertise required within our company's product technical operations team. The position will require SME level expertise in applicable protein chemistry with the expectation to be able to discern the multi-variant relationship between the purification process and product attributes at all steps within the process. The position will interface with our company product's product leaders, our company's product process development, and other product / process scientists within our Company. The position will involve predictive process monitoring as well as investigation of complex process deviations.

The successful candidate will have the opportunity to apply their enthusiasm, technical skills, and leadership skills as a member of a multidisciplinary team supporting vaccine manufacturing.

Assignment expectations include:

• Achieve Safety, Quality, and Environmental compliance excellence in all assignments
• Rigorous adherence to tier and IPT standard work
• execute on service level agreement expectations for the role
• Provide subject matter expert level leadership, coaching, and mentorship of tech ops and cross functional stake-holders
• Serve on the IPT specific tech ops leadership staff and contribute to organizational success by improving business processes and approaches. Expected to lead SME related initiatives
• Provide subject matter expert level leadership, coaching, teaching, and mentorship of tech ops and cross functional stake-holders. Work to develop future SMEs
• Manage portfolio of relevant area initiatives, prioritizing with cross-functional peers.
• Lead multidisciplinary teams within or across functional areas
• Develop SME level knowledge down to the unit operation level manufacturing process (process flow, CPPs, CQA, KOPs, KPA, device / equipment level). Should have SME level competency with DeltaV process interaction
• Lead and conduct technical investigations (including complex / significant) and analyses, recommending corrective actions, and seeing them through to successful, sustainable implementation
• Review and approve technical investigations. Teach and coach technical investigation skills (root cause, writing, and presenting).
• Develop change owner / task capability for Veeva and IPI level changes. Execute on change task responsibilities. When acting as change team member, develop SME level capability navigating change systems, cross-site change strategies, collaborating / aligning with multidisciplinary teams (CMC, etc.)
• Write, review, approve documentation for technical and regulatory compliance excellence
• Act as the primary regulatory inspection contact for the SME scope. Expected to interact directly with inspectors and contribute to effort to develop / author observation responses.
• required to be available for off-hours / extended hours work to include (but not limited to) execution of specific activities (batch troubleshooting, validation, process simulation, project execution), escalation and decision making of critical topics (safety, environment, asset, batch quality), regulatory inspections, and event level circumstances

Education Minimum Requirement:

• B.S. degree in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry or related life science or engineering discipline with four (4) years of relevant industrial experience. OR
• M.S. degree in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry or related life science or engineering discipline with two (2) years of relevant industrial experience. OR
• Ph.D. in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry or related life science or engineering discipline with one (1) year of relevant industrial experience

Required Experience and Skills:

• Demonstrated subject matter level knowledge of our product's process and product attributes
• Minimum of two years of experience in sterile manufacturing
• Experience with direct or indirect interaction with regulatory authorities
• Has independently authored and lead efforts to complete investigation level deviations
• Demonstrated ability to lead people via influence as opposed to formal reporting structures
• Demonstrated success in managing and delivering multiple technical deliverables
• Excellent technical, organizational, interpersonal, collaborative, and verbal/written communication skills - including excellent presentation skills and the ability to communicate with employees at all levels including senior management
• Strong problem-solving skills and a hands-on approach to problem solving, with a bias toward going to see problems for oneself in the field
• The ability to examine an issue from diverse perspectives (safety, compliance, maintenance, automation, equipment, process, and people) in order to best understand and resolve it
• Enthusiasm, confidence and initiative-taking ability needed for continuous learning and its applications
• Strong drive to succeed and to help others do the same

Preferred Experience and Skills:

• Experience working in a cGMP environment
• Biologics or vaccine processing experience
• Sterile processing experience
• Technical writing experience
• Project management
• In depth technical troubleshooting
• Participation in regulatory agency inspections

NOTICEFORINTERNALAPPLICANTS

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".

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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.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Posting End Date:08/21/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R309251