Associate Specialist, Downstream Improvement & Support

Associate Specialist Downstream Improvement And Support

The Elkhorn Downstream Manufacturing Process Team is seeking a highly motivated individual to fill the position of Associate Specialist Downstream Improvement And Support, within our Manufacturing Division.

This position is responsible for leading critical documentation and process improvement initiatives within the blending, sterile filling and packaging operations. The candidate must possess strong problem-solving skills and be able to utilize data for decision making. The candidate must also be able to provide guidance around product impact from technical or compliance deviations with minimal supervision.

The individual must embrace and be committed to establishing an empowered team culture, with the goal of each employee reaching their fullest potential and having accountability, authority and responsibility to one another, and the community. Enthusiasm for continuously learning and imparting that knowledge on others is a requirement.

Primary responsibilities include, but are not limited to the following:

• Write event notifications to document atypical events in production and lead investigations as necessary.
• Create CAPAs and change controls to drive downstream improvement.
• Develop process improvement procedures to improve downstream efficiency.
• Collaborate with other departments, such as Quality, Environmental Health and Safety, Technical Support, Planning, and Maintenance to ensure alignment of goals.
• Update batch records and procedures as per GMP requirements.
• Provide support to production floor on matters of quality and improvement.
• Investigate production variation and identify and implement improvement to improve and maintain process control.
• Update BOMs according to historical performance
• Update SPPs, SOPs and PPMs within the QMS
• Participate in annual Outline reviews and update as needed.

Education Minimum Requirement:

• High School diploma/GED with a minimum of 6 years of laboratory or related vaccine production experience OR
• Associates Degree with a minimum of 4 years laboratory or related vaccine production experience OR
• Bachelor's of Science degree with a minimum of 1 year laboratory or related vaccine production experience OR
• Bachelor's degree in Industrial Engineering.

Required Experience and Skills:

• Possess strong problem-solving skills and able to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve it at root cause.
• Team player with a "go-to-the-gemba" attitude, analytical & eager to learn. 4+ hour a day will be spent in production
• Ability to effectively communicate with stakeholders.
• Ability to gown into and work within an aseptic environment.
• Communication, leadership, and teamwork skills.
• Efficient and effective attention to detail, achieve a consistent error-free implementation of daily job assignments and complete documentation using Good Documentation Practices
• Proven ability to identify opportunities for process improvement
• Demonstrated skills with Microsoft Office applications and knowledge of system-controlled material usage through ERP environments such as SAP.
• Proven experience following SOPs, SPPs, checklists and other documented processes in a highly regulated industry. (USDA/FDA/EU)
• Ability to work independently and as part of a team

Preferred Experience and Skills:

• Experience in USDA or similarly regulated manufacturing environment.
• Expertise in the operation of batching and blending as well as high speed filling, capping and packaging operations.
• Lean and six sigma skills.
• Statistical math skills using Minitab or JMP.

Required Skills: Assembly Operations, Automation, Batch Production, Chemical Engineering, Cross-Team Coordination, Enterprise Resource Planning (ERP), Environment Health and Safety, GMP Compliance, Goal Alignment, HR Programs, Industrial Engineering, Machinery Operation, Mechanical Apptitude, Packaging Processes, Pharmaceutical Manufacturing, Pharmaceutical Quality Assurance, Process Improvements, Process Technologies, Production Efficiencies, Production Scheduling, Proper Documentation, Safety Protocols, Shift Work, Spreadsheet Software

Preferred Skills: 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.

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:

EEOC Know Your Rights

EEOC GINA Supplement

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.

Learn more about your rights, including under California, Colorado and other US State Acts

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".

The salary range for this role is $70,500.00 - $110,900.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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: No

VISA Sponsorship: No

Travel Requirements: 10%