Senior Specialist, Engineering

| West Point, PA, USA +80 more | Remote | Hybrid
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Job Description
Job Description:
The West Point PV (Polysaccharide Vaccine) organization is seeking a highly motivated Senior Specialist within the PV E2E Tech Ops Projects team. The successful candidate will have the opportunity to contribute to the performance and results of the manufacturing area by providing engineering/technical guidance and support for process, equipment, facility and analytical projects of varying complexity and size, including strategic site and network-wide initiatives.
Primary Responsibilities:

  • Leads, Supports, and/or executes process, equipment, and facility projects for the PV E2E.
  • Leads, Supports, and/or executes continuous improvement projects that increase compliance, reduce cost, and/or simplify/standardize the process.
  • Examines complex issues from diverse perspectives (safety, compliance, automation, validation, equipment, process, and people) to best understand and resolve the root cause.
  • Designs, authors, updates, and/or reviews and approves engineering, technical, and manufacturing documents (change control, validation documents, commissioning documents, etc.) necessary for engineering studies and project execution in a Good Manufacturing Practice environment.
  • Provides on-the-floor support for project implementation and studies, as required.
  • Leads or participates in Quality Risk Assessments.
  • Supports team safety, environmental, and compliance objectives.
  • Manages project timelines to ensure key compliance and customer due dates are met; escalates any potential delays and develops remediation plans when possible.
  • Collaborates effectively with Operations, Quality, Planning, project teams, and external vendors, anticipating and interpreting customer needs to identify and implement solutions.
  • Supports regulatory inspection activities.


Education Minimum Requirement:

  • B.S. Degree in Engineering or other equivalent technical fields.


Required Experience and Skills:

  • Minimum five (5) years' post-bachelors degree experience in a GMP functional area/manufacturing environment or support of a GMP functional area, such as Operations, Technical Operations, Technology, Engineering, and/or Maintenance; OR
  • Master's and 3 years of experience
  • 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.
  • Pharmaceutical/Biopharmaceutical experience


Preferred Experience and Skills:

  • Interested candidates must be capable of providing boundaryless application of leadership skills for project management and global change management while staying aligned with changing requirements and continuously identifying opportunities to improve the processes and support to our customers.
  • Experience in biologics, vaccine, or bulk sterile manufacturing facilities
  • Change Control author
  • Project Management
  • Six Sigma training


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.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
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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.
Learn more about your rights, including under California, Colorado and other US State Acts
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".
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:
Not Applicable
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
06/5/2024
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Job Posting End Date:06/06/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID:R296179

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What are Merck Perks + Benefits

Merck Benefits Overview

Our commitment to you
We promise a Merck experience based on
a foundation of…
Culture
We are committed to fostering an environment where all colleagues
feel welcomed, respected and valued.
Responsibility
We are committed to tackling the world’s biggest health challenges by
discovering better ways to make a difference in everything we do.
Career development
We are committed to encouraging professional career development that
aligns to our business strategy.
Rewards
We are committed to offering plans, programs and resources that provide
you and your family what you need, when you need it

Culture
Volunteer in local community
Partners with nonprofits
Open door policy
OKR operational model
Team based strategic planning
Open office floor plan
Employee resource groups
Flexible work schedule
Remote work program
Diversity
Documented equal pay policy
Dedicated diversity and inclusion staff
Mandated unconscious bias training
Diversity employee resource groups
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