Associate Specialist, Commissioning and Qualification Engineer

Job Description

The Associate Specialist, Engineering C&Q position will fill a new role at the Elkhorn facility in support of the Commissioning and Qualification team. This position is responsible for developing and executing C&Q protocols across the site. The associate specialist will be responsible for communicating with stakeholders for testing requirements and scheduling. They will work closely with multiple departments on site to ensure equipment and utility systems maintain their validated state and new systems meet GMP requirements. Additionally, the role may take on additional responsibilities to develop skills and meet needs of the Engineering and Maintenance department. This can include troubleshooting equipment, implementing process improvements, investigating site deviations, and updating calibration records.

Key Responsibilities

• Develop and execute commissioning, qualification, and validation protocols for equipment utilities and automated systems.

• Perform system start-up, troubleshooting and performance verification to ensure readiness for operation.

• Prepare and maintain C&Q documentation including protocols, reports, traceability matrices and risk assessments.

• Ensure compliance with USDA, 9CFR and other regulatory guidelines.

• Support the development and maintenance of validation master plans and user requirement specifications (URS).

• Collaborate with Quality Assurance to ensure documentation meets internal and external audit requirements.

• Work closely with Engineering, Maintenance, Manufacturing, Automation and Quality teams to ensure seamless project execution.

• Identify opportunities to optimize C&Q processes, reduce cycle times and enhance equipment reliability.

• Support change control activities and evaluate impact of modifications on validated systems.

• Contribute to the development of standard operating procedures (SOPs) for best practices.

Qualifications

Required Qualifications:

• Bachelor’s in Engineering required (Mechanical, Chemical, Electrical, Biomedical, Biochemistry or related discipline)

• Understanding of aseptic processing and equipment cleanability

• Strong analytical and problem-solving skills

• Ability to write technical reports with key data and conclusions clearly presented

• Ability to communicate and present information to groups with varied levels of technical background

• Ability to work independently and in cross-functional teams

Physical abilities include:

• Use various hand-held measuring devices and manipulate components with dexterity

• Sit, stand and walk for up to 8 hours or more per day

• Lift and carry up to 25 lbs. on a limited basis

• Climb stairs and ladders to access equipment components

• Work at a computer for up to 8 hours per day

• Tolerate working in unconditioned spaces ( ≥30°C) on a limited basis

Preferred:

• Technical understanding of equipment and utility systems such as HVAC, purified water, clean steam, fermentors, bioreactors, autoclaves, and temperature control units including coolers, freezers, and incubators

• Hands-on experience in commissioning, qualification or validation within the pharmaceutical, biotech, or related manufacturing industry

• Awareness of Good Manufacturing Practices (GMP) in regard to documentation

• Aseptic processing experience

• Comfortable managing multiple priorities in a fast-paced environment

Other Considerations:

Limited off shift work may be required to meet project, operations, and qualification needs

Travel: Less than 10% travel required

Required Skills:

Accountability, Accountability, Adaptability, Biochemistry, Biopharmaceutical Operations, CAD Proficiency, Change Control Processes, Communication, Construction, Data Analysis, Engineering Principle, Engineering Standards, Estimation and Planning, Experimentation, External Audit, Gauging, GMP Compliance, Good Manufacturing Practices (GMP), High Technology Industry, Immunochemistry, Mechatronics, Process Improvements, Process Optimization, Professional Engineering, Project Management {+ 4 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

$71,900.00 - $113,200.00

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:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

01/21/2026

*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.