Job Description
Position Description:
We currently have an exciting opportunity for a Senior Engineering Specialist to join our Technical Support Operations department within the Manufacturing Division (MD), supporting the manufacturing facility in Durham, NC.
In this role, you will serve on the Technical Operations Integrated Process Team (IPT) support team focusing on process related problems, projects, and initiatives. You must be able to work efficiently in a fast-paced environment and be hands-on when called for by the situation. The position requires strong leadership, technical writing, and problem solving skills.
You may lead and/or support critical project initiatives at the site, support the manufacturing process, and maybe involved in conducting scientific investigations and data analysis to determine root cause, product impact and develop corrective actions for unexpected results. The ability to design and strengthen process systems meeting both Quality and Supply needs is a must. Enthusiasm for continuously learning is a requirement. 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, our community and our patients. Off-shift or weekend coverage may be required occasionally, based on project-specific assignments.
Primary Responsibilities
Lead initiatives supporting the End to End manufacturing process
Lead as Technical Operations Subject Matter Expert (SME)
Leads/Supports production and quality projects and process system improvements
Facilitates real-time formal problem solving techniques, such as root cause analysis and/or Lean Six Sigma tools.
Support investigations of process deviation events
Provide technical expertise and oversight on the production floor, understanding the full process requirements (safety, compliance, equipment, regulatory) in order to best understand and resolve production issues.
Education Minimum Requirement
Bachelor of Science (B.S.) degree in Engineering (such as Chemical, Mechanical, Bio-Engineering, Bio-Medical Engineering, industrial Engineering, etc.) or Science Fields (such as Chemistry, Biology, Microbiology, etc.) with relevant experience.
Required Experience and Skills
Minimum six (6) years of experience in a pharmaceutical Good Manufacturing Practices (GMP) related environment.
Working knowledge of current Good Manufacturing Practices (cGMPs) and of regulatory requirements as they apply to the vaccine/pharmaceutical industry.
Experience with formal problem solving techniques and a hands-on approach to problem solving, such as root cause analysis and/or Lean Six Sigma tools.
Experience in project management
Technical writing experience, i.e. investigations, change requests, standard operating procedures, batch records, protocols.
Must be able to work both independently and within multi-functional teams in a fast-paced environment
Preferred Experience and Skills
Experience with presenting to an internal / regulatory auditor.
Skills in design of experiments (DOE)
Experience leading and/or facilitating a team for problem solving / investigative purposes.
Advanced knowledge of Excel, Minitab, JMP, and/or Statistical analysis
Sterile manufacturing experience
Six Sigma certification
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:
EEOC Know Your Rights
EEOC GINA Supplement
Pay Transparency Nondiscrimination
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.
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”.
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:
Hybrid
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
12/3/2024
*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.
