Senior Statistical Programmer, Late Stage Development, Oncology (Hybrid) - Military Veterans

Job Description

Position Description

The Barrier Operations Technical Operations team is seeking a highly motivated individual to provide technical and engineering support as Senior Specialist process engineer. Areas within scope of Barrier Operations include multi-product liquid vaccine formulation (closed processing), aseptic vial filling, and aseptic syringe filling. The successful candidate will have the opportunity to apply his or her enthusiasm and technical skills as a member of a multidisciplinary team supporting the operation and improvement of a vaccine manufacturing facility with a focus on process engineering.

Responsibilities may include:

• Serves as the subject matter expert (SME) for a liquid vaccine manufacturing process within Barrier Operations


• Monitors process and equipment performance, and partners with maintenance/operations/ reliability engineering to proactively identify and implement process improvements


• Provides assessment of impact for proposed changes to manufacturing steps or equipment


• Supports or leads projects to improve the performance of our processes, including investigation Corrective/Preventative Actions (CAPAs), projects aimed at improving Right-First-Time performance or preventing/reducing deviations, and value capture projects that seek to improve yield/efficiency, reduce cost, or lower our processing cycle times


• Collaborates effectively with the area, operators/mechanics, support groups, Quality, planning, project teams, and external component and equipment vendors


• Provides direct shopfloor support or mentors others in response to shop floor events and process upsets, including input to deviation management and product leads


• Support of regulator inspections and compliance driven actions


• Leads technical discussions, and maintains technical process documentation


• Authors, updates, and/or reviews and approves technical and manufacturing documents necessary for engineering studies, protocols, and change control


• Supports team safety, environmental, and compliance objective


• Supports, executes, and/or leads continuous improvement projects that increase compliance, simplify/standardize and/or gain efficiencies.


• Manages project and investigation timelines to ensure key compliance and customer due dates are met; escalates any potential delays and develop remediation plans when possible.

Education Minimum Requirement:

• B.S. degree in Engineering or Science field such as chemical engineering, biochemical engineering, mechanical engineering, biological system engineering,

Required Experience and Skills:

• Minimum five (5) years experience in a GMP functional area or support of a GMP functional area, such as Operations, Technical Operations, Engineering, and/or Maintenance


• Strong verbal and written communication skills; interpersonal and team skills; and collaborative skills


• Demonstrated ability to proactively identify and implement process improvements


• Excellent troubleshooting and problem solving skills


• Demonstrated technical, analytical, and organization skills


• Experience in supporting vaccine manufacturing or sterile processing


• Hands-on technical services experience in supporting formulation and filling, including manufacturing-scale filling isolators and closed system processing

Preferred Experience and Skills:

• Aseptic filling experience, specifically vial filling or syringe filling line


• Change control author or approver


• Project management experience


• Regulatory inspection experience


• Strong leadership skills

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.

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.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. 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 diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas 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

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:
Domestic

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Not Applicable

Shift:
Not Indicated

Valid Driving License:
No

Hazardous Material(s):
n/a

Job Posting End Date:
10/18/2024
*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.