Senior Specialist, Engineering

Job Description

Overview

The Sr. Specialist in Biosafety and Biotechnology Solutions is responsible for managing an effective biosafety program while supporting production troubleshooting, vaccine process development, and key business initiatives at the Elkhorn Animal Health site. This role will ensure compliance with biosafety regulations and promote best practices across various departments, fostering a culture of safety and continuous improvement.

Reporting Structure

This position sits within the Global Safety & Environment organization and reports to the Director of Environment, Health & Safety at Elkhorn, NE; while also collaborating closely with the Director of Biotechnology Solutions.

Key Responsibilities

• Biosafety Management:
  
  • Develop, implement, and maintain biosafety programs and policies in compliance with local, state, and federal regulations (CDC, NIH, OSHA).
  • Review and conduct risk assessments for biological materials and laboratory operations to identify potential biohazards.
  • Facilitate the safe handling of biological agents from Risk Group 1 through Risk Group 3 for small and large-scale operations and animal testing.
  • Develop and deliver training programs on biosafety practices, laboratory safety procedures, and emergency response protocols.
  • Investigate biosafety incidents and develop corrective actions to prevent recurrence, maintaining records and ensuring proper reporting to regulatory authorities.
  • Conduct biosafety program reviews for the site.

• Biotechnology Solutions Support:
  
  • Lead production investigations and support daily technical activities within production, implementing process improvements.
  • Collaborate with departments such as Quality, Environmental Health and Safety, Technical Support, Planning, and Maintenance to ensure alignment of goals.
  • Provide guidance on product impact from technical or compliance deviations with minimal supervision.
  • Understand and lead process development capabilities within the Biotechnology Solutions development lab.
  • Understand and lead tech transfer

• Collaboration and Culture:
  
  • Create an open culture of learning, acceptance, and respect within the team and across departments.
  • Promote a culture of safety and biosafety awareness throughout the organization.
  • Prepare for and facilitate external audits and inspections related to biosafety and biotechnology processes.

Education

• Bachelor's degree in Microbiology, Public Health, Occupational Health, Safety, Engineering, or a related field.
• Master's degree in a related discipline is preferred.
• Certified Biological Safety Professional (CBSP) or equivalent is highly desirable.

Experience

• Required:
  
  • Minimum of 5 years of experience in biosafety, biosecurity, or related fields, with demonstrated expertise in laboratory safety and risk assessment.
  • Minimum of 3 years of laboratory or related vaccine production experience in an academic, FDA, or USDA-regulated setting.

• Preferred:
  
  • Prior experience supporting an FDA or USDA-regulated manufacturing environment.
  • Experience with vaccine or large molecule process development.

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:

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
$104,200.00 - $163,900.00

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 ;br>
You can apply for this role through (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 relocation

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Not Applicable

Shift:
Not Indicated

Valid Driving License:
No

Hazardous Material(s):
N/A

Required Skills:
Biostatistics, Biostatistics, Change Control Processes, Coaching Managers, Computer Technical Support, Detail-Oriented, Deviation Management, Driving Continuous Improvement, Engineering Standards, Health Safety, Health Safety Regulations, Immunochemistry, Innovation, ISO 45001, Laboratory Safety, Manufacturing Process Improvements, Materials Science, Occupational Safety and Health, Packaging Engineering, Packaging Equipment, Packaging Innovation, Packaging Operations, Process Improvements, Production Support, Sealing Machines {+ 1 more}

Preferred Skills:

Job Posting End Date:
08/18/2025
*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.