Job Description
Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you!
Our Engineers assist internal and external manufacturing operations to remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.
Our ability to excel relies on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, youll have the opportunity to partner with talented and dedicated colleagues while developing and expanding your career.
The Specialist, Technical Operations Engineer in this position within the Incoming Materials Integrated production team (IPT) within the Shared Services End to End (E2E) will be accountable for providing technical support and execution of Vendor Change notifications. They will be accountab for providing and occasionally leading technical assistance to the manufacturing areas.
The individual will work as an individual contributor, adding to the performance and results of the department, provides technical guidance, anticipates and interprets client and/or customer needs to identify and implement solutions.
Minimal supervision, guidance, and direction is employed by the supervisor, however, periodic checks and reports are required to review soundness of technical judgment and the status/schedule of the effort. Individual will also be accountable for:
* Support and/or execution of continuous improvement projects that increase compliance, simplify/ standardize and/or gain efficiencies.
* Examination of an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best comprehend and resolve the root cause.
* Design and conduct experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale.
* Authoring and updating technical and manufacturing documents necessary for engineering studies, change control.
* Assist with regulatory inspection activities for the facility
* Providing on-the-floor assistance of operational and technical (process/equipment) issues on the shop floor.
* Completing projects to improve the performance of our processes, including investigation Corrective/Preventative Actions (CAPAs), projects aimed at improving Right-First-Time performance or preventing/reducing deviations, and value capture projects that seek to improve yield/efficiency, reduce cost, or lower our processing cycle times.
* Promoting team safety, environmental, and compliance objectives.
* Managing project and investigation timelines to ensure key compliance and customer due dates are met; escalating any potential delays and develop remediation plans when possible.
* Collaborating effectively with the area Coaches, Operators/Mechanics, support groups, Quality, and Planning
Education Minimum Requirement:
* Bachelors Degree or higher (Engineering or Sciences, preferred)
Required Qualifications and Skills:
* Two (2) years post-bachelors degree experience in GMP manufacturing/laboratories and/or technical support of GMP manufacturing operations/laboratories.
* Experience in deviation management and/or change control and/or equipment support and/or project support role.
* Highly developed communication, leadership and teamwork skills.
* Ability to manage projects/work to schedule/deadlines.
Preferred Qualifications and Skills:
* Experience in biologics, vaccine, or bulk sterile manufacturing facilities.
* Change Control Author
* Deviation Management Investigator
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 Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD 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:
No relocation
VISA Sponsorship:
Travel Requirements:
No Travel Required
Flexible Work Arrangements:
Not Specified
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
Number of Openings:
2
Requisition ID:R99357
Kenilworth, NJ
Merck & Co., Inc. provides healthcare solutions worldwide. It operates through four segments: Pharmaceutical, Animal Health, Healthcare Services, and Alliances. The company offers therapeutic and preventive agents to treat cardiovascular, type 2 diabetes, chronic hepatitis C virus, HIV-1 infection, intra-abdominal, fungal infection, insomnia, and inflammatory diseases. It also provides neuromuscular blocking agents; cholesterol modifying medicines; and anti-bacterial and vaginal contraceptive products.
In addition, the company offers products to prevent chemotherapy-induced and post-operative nausea and vomiting; treat non-small-cell lung, ovarian and breast, thyroid, and cervical cancer, as well as brain tumors; and prevent diseases caused by human papillomavirus, as well as offers vaccines for measles, mumps, rubella, varicella, shingles, rotavirus gastroenteritis, and pneumococcal diseases.
Further, it provides antibiotic and anti-inflammatory drugs to treat infectious and respiratory diseases, fertility disorders, and pneumonia in cattle, bovine, and swine; vaccines for poultry; parasiticide for sea lice in salmon; and antibiotics and vaccines for fishes. Additionally, the company offers companion animal products, such as ointments; diabetes mellitus treatment and anthelmintic products; products to treat fleas and ticks in dogs and cats; fertility management products for horses; vaccines for dogs, cats, and horses; and products for protection against bites from fleas, ticks, mosquitoes, and sandflies.
It has collaborations with AstraZeneca PLC; Bayer AG; Eisai Co., Ltd.; and Intec Pharma Ltd. The company serves drug wholesalers and retailers, hospitals, government agencies and entities, physicians, distributors, veterinarians, animal producers, and managed health care providers. Merck & Co., Inc. was founded in 1891 and is headquartered in Kenilworth, New Jersey.