Spclst, Engineering

Job Description

Job Description: 

Our Research Scientists are our Inventors. We identify and target steps in disease mechanisms or pathways that could be inhibited or enhanced. Our goal is to isolate a compound that is effective against a disease target. Using innovative thinking, state-of-the-art facilities, and robust scientific methodology, we collaborate to discover the next medical breakthrough. 

The Process Operations Specialist is responsible for leading and executing GMP bioreactor operations in support of clinical manufacturing campaigns, ensuring consistent execution of upstream processes and supporting integration with other process areas. The Specialist applies technical knowledge, problem solving and leadership skills to deliver high-quality, compliant biomanufacturing operations. 

Key Responsibilities: 

• Execute GMP batch records for upstream bioreactor operations across scales ranging from benchtop to 2000L in stainless steel, glass, and single-use systems. 

• Lead small teams in the preparation, setup, operation, and teardown of bioreactors and associated support systems. 

• Perform in-process monitoring, sampling, and real-time data review to ensure process performance and compliance. 

• Troubleshoot process and equipment issues, collaborating with engineering, process development, and quality functions to resolve deviations and maintain production flow. 

• Support new process introduction, scale-up activities, and technical transfer into GMP operations. 

• Maintain and complete GMP documentation, including batch records, logbooks, and deviation reports in compliance with regulatory and site standards. 

• Promote a strong safety culture and adherence to environmental, health and safety procedures. 

• Participate in continuous improvement initiatives focused on process robustness, equipment reliability, and operational efficiency. 

• Train and mentor less-experienced staff in GMP operations, equipment use, and documentation practices. 

 

#PRD

Education: 

• Bachelor’s degree in biology, biotechnology, chemical engineering, or related field with a minimum of 2 years of relevant experience, or  

• Master’s degree with a minimum of 1 year of relevant experience. 

 

Experience: 

Required:

• Hands-on experience with bioreactor operations. 

Preferred:

• Experience with DeltaV and/or Unicorn control systems strongly preferred. 

• Working knowledge of GMP documentation, deviation management, and aseptic technique. 

• Familiarity with upstream and downstream unit operations in biopharmaceutical manufacturing. 

• Proven ability to lead teams. 

Key Attributes: 

• Strong ownership and accountability for assigned tasks and team outcomes. 

• Ability to work effectively in a team-based matrixed environment. 

• Flexible and adaptable to changing priorities, including off-shift work as needed. 

• Excellent attention to detail, communication, and documentation skills. 

• Commitment to maintaining the highest standards of safety, quality, and compliance. 

Required Skills:

Adaptability, Adaptability, Aseptic Technique, Biomanufacturing, Biotechnology, cGMP Guidelines, Chemical Biology, Chemical Engineering, Chemical Technology, Electronic Batch Records, GMP Compliance, Laboratory Experiments, Mammalian Cell Culture, Occupational Health and Safety Management, Personal Initiative, Pilot Plant Operations, Process Design, Process Engineering, Process Optimization, Product Formulation, Safety Standards, Standard Operating Procedure (SOP) Writing, Standards Compliance, Sterile Manufacturing, Teamwork {+ 2 more}

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. 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

$85,600.00 - $134,800.00

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 relocation

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:

01/4/2026

*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.