Job Description

Job Description

The Senior Specialist, Technical Operations is responsible for technical support for vaccine manufacturing unit operations while actively supporting, participating in, and embracing an empowered team culture. In this role, the Specialist will work as an individual contributor as well as a team within a cross-functional group that includes Global Engineering Services, Global Technical Operations, West Point Operations, Quality, Automation, and others.

Additional responsibilities include:

* Support successful demonstration of unit operations for the technology transfer of vaccine manufacturing process to the new manufacturing facility

* Partner with the cross-functional team to develop process/procedures and complete successful qualification of equipment/process.

* Provide technical expertise for unit operation for design reviews, process hazard assessments, quality risk assessments, factory, and site acceptance testing, qualification

* Author and update technical and manufacturing documents necessary for process design/definition, engineering studies, process demonstrations, and validation.

* Develop and execute change control inclusive of change definition, risk assessments, impact assessments, task execution, implementation, and support of associated regulatory filings

* Support process improvement projects and complex manufacturing investigations

* Support digital and data integrity initiatives for the project

* Provide technical support to manufacturing for complex problems and issues

* Develop and assure consistent application of standardized work, engineering, and process tools

* Examine issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause

* Support regulatory submission preparation and inspections for the facility

Qualifications:

Required:

* Bachelors degree in an Engineering or Science related field

* Minimum 5 years of experience in GMP manufacturing and/or technical support of GMP manufacturing operations; Minimum 4 years with a Masters Degree.

* Demonstrated a strong performance record and have excellent project management skills.

* Experience in biologics, vaccine, or bulk sterile manufacturing facilities

* Highly developed communication, leadership, and teamwork skills.

Preferred:

* Experience leading and managing departmental or cross-functional teams

* Regulatory inspection presentation experience with external regulatory authority representatives

* Strong understanding of process risk assessment tools, Quality by Design principles, and Lean/Six Sigma methodologies/certification



Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network thats devoted to delivering a high quality, reliable supply to customers and patients on time, every time.

Who we are

We are known as Our Company., Inc., Kenilworth, New Jersey, USA in the United States and Canada and Our Company everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

INVENT.

IMPACT.

INSPIRE.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

US and Puerto Rico Residents Only:

If you need an accommodation for the application process please email us at staffingaadar@msd.com
For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement

OFCCP EEO Supplement

OFCCP Pay Transparency Rule

We are an equal opportunity employer, Minority/Female/Disability/Veteran proudly embracing diversity in all of its manifestations.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:

Shift:

1st - Day

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1
Requisition ID:R98998