Merck & Co., Inc.

Operations Specialist

Posted on: 11 Apr 2024

Millsboro, DE

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.

Our Company's Animal Health Division (AHD) is a BioTechnology Center of Excellence that performs vaccine production operations from antigen production through formulation, filling, and packaging. 

Position Description:

With expertise in mammalian, insect, and avian cell culture production (anchorage & non-anchorage dependent), live bird vaccine production, embryonated egg vaccine production, roller bottle vaccine production, bioreactor vaccine production, down-stream processing, formulation, and fill technologies (water in oil emulsions, aseptic filling, lyophilization, etc.), supplies and supports products for a wide range of species including poultry, equine, swine, bovine and companion animal. 

This position will assist the Integrated Process Team Lead (IPT) and the Operations Manager to support the shop floor staff to ensure delivery of daily production outputs in a safe and compliant manner and is reinforcement in nature to allow more manager presence.   

Responsibilities 

Deputy shift manager 

Execute and deliver improvements of quality, safety, productivity, and variation reduction

Deviation prevention | Coach and provide oversight on the shop floor to identify potential issues before they arise

Document and investigate deviations and safety events to determine root causes | Develop, execute, and sustain CAPAs once the root cause is determined

Organize and complete audits and inspections (safety, compliance, 5S, etc.) 

Complete process confirmation for Task Breakdown Sheets, SOPs, and other job instructions

Respond to issues on the shop floor and escalate as necessary.

Education Requirements:

Required:

High School diploma or equivalent

Preferred:

Associates' degree in a related Science, Engineering or other technical discipline

Bachelor’s degree in a related Science, Engineering or other technical discipline

Experience and Skills:

Required:

Four (4) or more years of relevant experience in the vaccine and/or pharmaceutical Industry

One (1) or more years of demonstrated leadership and project management experience

Applied knowledge of aseptic techniques and aseptic operations

Applied knowledge of scientific problem-solving

Applied understanding of cGMP

Demonstrated record of learning new skills, taking on new responsibilities, and continuously improving leadership skills

Principled motivation and ambition to advance into manufacturing management roles

Principled communication skills (Verbal and Written)

Ability to read, write and understand technical information as well as communicate this information to colleagues at various levels

Conduct and verify more advanced mathematical calculations and conversions (Statistics, metric conversions, etc.)

Proficient in Microsoft Office (Excel, Word, PowerPoint, Outlook)

Preferred:

Working knowledge of SAP and Minitab  

Experience with sterile manufacturing equipment and processes 

Strategic and effective leadership and coaching skills and interest in people development and management

Working knowledge of USDA, and OSHA compliance  

Experience with and exposure to Lean coaching methodologies (Kata, etc.) 

Position may require contact with various hazardous materials using appropriate Personal Protective Equipment

Schedule:

Could include Day | Night | Weekends

Merck & Co., Inc.

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.