Senior Specialist, Engineering (Deviation Management)

Job Description

Our Engineers support internal and external manufacturing operations remaining operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.

We are seeking a Growth and Improvement minded individual to lead a Deviation Management team within Polysaccharide Vaccines that can help drive our Strategic Operating Priorities.

• Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs
• Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)
• Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape
• Diverse Talent | We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world
• Values and Standards | Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success – They are a Competitive Advantage for Us

Summary:

As part of our Manufacturing Division, Polysaccharide Vaccines Technical Operations at West Point is seeking a highly motivated leader to partner with the Operations, Quality Operations, and Regulatory groups by leading a deviation management team to meet targeted supply and compliance initiatives. This position will require development of technical expertise of corresponding IPT operations and mentorship/development of more junior members of the deviation management team. Polysaccharide Vaccines includes fermentation processing, vaccine purification, media preparation, bulk formulation, sterile filtration, and manufacture of conjugate vaccine processes.

Key Responsibilities:

• Leads/manages a deviation management team of up to five investigators and provides mentorship/development of more junior team members and contractors.
• Conducts more complex investigations and drives to appropriate root causes and corrective actions.
• Collaborates with IPT Operations, Technical Operations, and Quality leadership to identify deviation trends and establish continuous improvement opportunities to reduce potential deviations.
• Coordinates and prioritizes deviations based on investigator, batch ROT, and supply.
• Reviews deviations with regulatory agencies and provides health authority reporting as required.
• Has ability to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.
• Assures consistent application of standardized work, engineering and process tools.
• Authors and updates technical and manufacturing documents necessary for investigations, process design/definition, engineering studies, process demonstrations, change control and validation.
• Provides technical guidance to staff, colleagues or customers as well as anticipates and interprets the customer needs to identify solutions. Includes approval of technical documentation including investigations, protocols, reports, etc. as required.

Education:

• Bachelor's Degree in Chemical Engineering, Biological Sciences or other related science or engineering field with four (4) years relevant work experience, including direct support of development or manufacturing of biologics or sterile products.

Required Experience and Skills:

• Demonstrated leadership and ability to drive results
• Strong communication, collaboration skills and ability to drive accountability
• Strong problem-solving skillset
• Experience authoring investigations

Preferred Experience and Skills:

• Vaccine manufacturing
• Participation in regulatory inspections
• Prior management experience

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

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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 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”.

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.

Employee Status:

Regular

Relocation: