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Associate Principal Scientist, Statistical Programmer Oncology (Hybrid) - Military Veterans

at Merck & Company

Job Description

The Senior Maintenance Technician is responsible for providing equipment troubleshooting and maintenance support for a new product feasibility project/manufacturing support. Support updates to standard operating procedures (SOP's) and preventative maintenance (PM's) plans, as requested. Responsible for written documentation of activities. Responsible for SAP transactions and change control activities including spare part lists and Preventative Maintenance (PMs) plans. Actively supports, participates, and embraces an inclusive team culture including significant interaction with Operations, Quality, Automation, Technology, and other groups as required.

Responsible for supporting:


  • Process Equipment (e.g. tanks/bioreactors, filtration skids, chromatography columns)

  • Support Equipment (e.g. washers, autoclaves, tube welders/sealers, WFI stills, Clean steam generation)

  • Automated Systems (e.g. Distributed Control System (DCS), Programmable Logic Controllers (PLC), robotics, Building Automation System (BAS))

  • Clean-In-Place (CIP) Systems

  • Maintenance Equipment (e.g. tools and calibration equipment)

  • Support to Digital Platforms (e.g. SAP, ProCal, Brady)

  • Initiate and complete routine calibration tasks, work with and troubleshoot complex process systems

  • Contributes to the performance and results of the department

  • Identifies and resolves technical and operational problems; collaborates with peers to resolve problems that cross into inter-related units

  • Assisting in the identification, development, and implementation of new systems which enhances the operation and/or engineering processes

  • Decisions are guided by policies, procedures, and business plan; receives guidance from manager

  • Manage multiple priorities and advance several tasks in parallel



Must be flexible to perform all the following functions and other tasks, as needed:

  • Ability to work with and troubleshoot complex process systems to include bioreactors, filtration skids, chromatography columns, washers, autoclaves, and CIP skids.

  • Testing, adjustment, maintenance, repair, calibration and troubleshooting of complex automated process equipment.

  • Support updates of standard operating procedures (SOPs), preventative maintenance (PM) plans/calibration procedures, task lists, etc., as required.

  • Identify spare parts for preventive maintenance plans.

  • Interface with other departments, contractors and disciplines on scheduling repairs and maintenance of clean utility systems

  • Assists with execution of automation, validation, and additional testing, as required

  • Responsible for written documentation of activities

  • Completes preventative maintenance and calibration work orders, resolves deviations, and evaluates equipment performance for efficient operation.

  • Efficient and safe maintenance and repair of equipment using Hazardous Energy Control Procedures

  • Compliance with current good manufacturing procedures(cGMP), safety and environmental requirements/regulations/guidelines

  • Effective maintenance, troubleshooting, and problem-solving skills required

  • Ability to manage multiple priorities and advance several tasks in parallel

  • Demonstrated instrumentation aptitude

  • Proficient in the use of general hand and power tools, instruments and testing apparatus commonly used in maintenance and instrumentation.

  • Ability to read P&ID's, electrical drawings, blueprints, etc.

  • Routine shift will be 2-2-3, 12-hour day shift schedule, including holidays and alternating weekends. Required to support an on-call schedule for off-day and weekends. Successful candidate will be required to work an 8-hour weekday schedule until shift is required.



Required Education and Experience:

  • High School Diploma/GED or higher

  • Two years of plant maintenance and/or calibration experience with knowledge of technical craft skills (instrumentation, electrical, plumbing, advanced mechanical, HVAC, and/or multi-stage refrigeration systems)

  • Required Experience and f amiliarity of regulatory requirements in accordance with GMP manufacturing operations



Preferred Education and Experience:

  • Five years of plant maintenance and/or calibration experience with knowledge of technical craft skills (instrumentation, electrical, plumbing, advanced mechanical, HVAC, and/or multi-stage refrigeration systems

  • Associate's degree in industrial systems, Mechanical, Electronics, Electrical or Instrumentation

  • Experience working in a clean room or GMP/regulated manufacturing environment

  • Operation, maintenance and/or troubleshooting experience with automated process equipment in the biopharmaceutical field

  • Experience with GMP compliant calibration and/or maintenance database systems.

  • Knowledge of SAP and DeltaV and Procal.



Physical Requirements:

  • Willing and able to lift 50 pounds, climb ladders and stairs, work on platforms and equipment above floor level.

  • Walking, bending, crawling and stooping are required.


  • Required to wear personal protective equipment including safety glasses, earplugs, gloves, hard hats, safety harnesses, etc.

  • Position requires clean room gowning during performance of job duties



Skills:

  • Effective communication both written and oral

  • Effective Calibration/Instrumentation Skills

  • Effective maintenance, troubleshooting, and problem-solving skills

  • Working knowledge of regulatory requirements in accordance with GMP manufacturing operations.

  • Proficiency in computer systems and applications including but not limited to: Microsoft Office (Word, Excel and Outlook), Programmable Logic Controllers (PLCs), CMMS Calibration/Maintenance Database Systems.

  • Must demonstrate adept leadership skills.

  • Strong planning, scheduling, and time management skills.

  • Available for "On-Call" work rotation (during off-hours) and weekend overtime, as needed.



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. VETJOBS TechnicianDurham MSJR #EBRG

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:

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.

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:

Shift:
1st - Day

Valid Driving License:
Yes

Hazardous Material(s):
cleaning supplies

Durham, NC

Merck & Company

Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com.

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