Associate Specialist, Validation and Process Support

Job Description

Job Description

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.

Responsibilities:

• Lead, execute, and document validation activities for initial validation and continuing validation.
• Author and review protocols, change controls, CAPA’s, deviations, SOP’s and technical reports.
• Collect and interpret information to conceive, develop, and implement solutions to a range of projects and support activities.
• Maintain alignment with internal technical personnel regarding validation practices for equipment, processes and products.
• Partner with Operations, Quality, and Technology functional areas on validation study implementation which may require off-shift and weekend execution.
• Investigate and resolve validation test failures and/or atypical events which require an application of a variety of investigational techniques and analysis, and cross-functional partnering to draw sound scientific conclusions with respect to validation compliance and/or product quality impact.
• Maintain current Good Manufacturing Processes (cGMP) compliance posture with respect to validation and manufacturing activities.
• Support all quality and safety initiatives.
• Foster empowered teams to achieve site mission, vision, and goals through efficient and safe operation of process systems, compliance with cGMPs resulting in product that is safe and efficacious.
• Experience with MS Office & enterprise applications (example: LIMS, Trackwise, etc) preferred.
• Support other duties as assigned by management.

Education Minimum Requirement:

• B.S. in Engineering, Science or equivalent related field.

Preferred Experience and Skills:

• Demonstrated ability to work both independently and as a part of a team.
• Familiarity with current validation regulatory requirements and best practices.
• Strong technical problem-solving abilities.
• Demonstrated effective written and verbal communication skills; ability to influence both peers and management in consensus.
• Strong collaboration and leadership skills.
• Sustaining the validated state through change management and continuing validation studies.

Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time.

Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.

We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.

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 [email protected]
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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R64342