Description

Job Description

Our Engineers support internal and external manufacturing operations 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.

Job Description:

Position tasks:

• Promote primarily the validation of computerized Analytical and or production systems as per System Development Life Cycle guidelines, updated Code of Federal Regulations Data Integrity standards, and other regulatory guidelines.
• Partnering with analytical research and development laboratories, computer systems quality, IT technical liaisons, and various software and instrument vendors/manufacturers to deliver technically complaint and analytically functional equipment
• Manage lifecycle of equipment, through capital purchasing, asset management, coordination of calibration & maintenance activities, and Deviation / CAPA / change management.
• Solutions orientated mindset with the ability to handle multiple high priority tasks at once.
• Planning and execution of the qualification of equipment and systems as well as validation of processes together with the equipment/process owner, supporting contractors and vendors
• Assist training new employees in equipment qualification, risk assessments and validation exercises
• Customer focused mindset with the ability to communicate adequately (verbally/writing) to all levels within the organization.
• Partner with operationally based teams (C/M, Validation, Quality, Sample Management) and analytical-based teams to support safety concerns, regulatory tracking, advocacy support, technical expertise, risk mitigation efforts and technical training.
• Author and review SOPs as necessary.
• Demonstrated ability to create and analyze detailed, cross-functional project plans, and manage execution and change against those plans.
• Ability to succeed in a dynamic environment; flexibility to respond to changing priorities.
• Well-developed and effective team facilitation and leadership skills; able to establish inclusive team environments.
• Ability to manage ambiguous situations to reach practical solutions.

Education:

• Bachelor's degree in biology, chemistry, biochemistry, bioengineering or related sciences and a minimum of 4 years of experience in a combination of the following: biologics and/or vaccine method development, equipment support, validation, and compliance.

Knowledge and Skills:

• Direct knowledge of operating analytical instrumentation within a pharmaceutical or equivalent laboratory (vaccine or large molecule focus).
• Ability to thoroughly review and scrutinize validation regulations through the life cycle of the system.
• Able to perform validation activities as a self-directed author while conferring with the business, technical, and quality approvers.
• Ability to self-regulate and prioritize based on communications from management and various project teams (e.g. time management).
• Ability to author and review specific technical documents including GMP/GLP, change control, formal SOPs, system validation protocols, etc.
• Capability to manage individual components of a project, prioritize well, and work cross-functionally
• Proven organizational skills, good communication and problem-solving abilities
• Good technical, communication (oral and written), interpersonal, and teamwork skills
• Self-motivated with a positive attitude and proven performance record

Preferred Knowledge and Skills:

• 5+ years of knowledge participating in the validation of computerized laboratory systems or instruments (e.g. system Installation and Operational qualification, Performance qualification)
• Knowledge of system lifecycle management

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.

Who we are ...

We are known as Merck & Co., Inc., Rahway, 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 ...

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us-and start making your impact today.

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.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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.

For more information about personal rights under Equal Employment Opportunity, 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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Learn more about your rights, including under California, Colorado and other US State Acts

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:
No relocation

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Flex Time

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
No

Requisition ID:R232852