AddressJob Description
This position for an Engineer will be responsible for providing engineering support at the Rahway non-sterile operations within Our Company's Research Labs Pharmaceutical Sciences (Pharm Sci), Pharmaceutical Operations Engineering group (Pharm Ops Engineering).
Non-sterile operations plays a crucial role in formulating and filling clinical, stability, and developmental supplies for Oral Solid Dosage (OSD) and Inhalation products. The Engineer will specifically support critical program needs related to new products undergoing process development, scale-up, launch and transfer to the supply network, and process optimization for existing commercial products.
The primary responsibility of this role will be to maintain all equipment in compliance with GMP (Good Manufacturing Practices) and Safety requirements. This includes implementing Reliability Maintenance best practices to ensure the timely availability of Clinical Supplies and Development Batches, meeting the requirements of the Clinical Development Program. Regular interaction with Partner Groups such as Facilities Management (FM/GWES) and Original Equipment Manufacturers (OEM) will be necessary. Collaboration and interface with the OSD Business area will also be required to ensure manufacturing activities are not delayed.
The Engineer will contribute to design input, specification development, and hands-on troubleshooting to ensure process equipment (manufacturing and packaging) and utilities remain functional and available to meet schedule demands. This will encompass understanding P&IDs, electrical drawings, basic PLC (Programmable Logic Controller) operation and function, electrical and mechanical component operation, familiarity with HVAC (Heating, Ventilation, and Air Conditioning), and knowledge of applicable tools, instruments, and troubleshooting techniques. The ability to provide hands-on support, mechanical solutions/options, and prompt responses is essential.
Additionally, the Engineer will provide engineering and quality engineering (QE) support to ensure facilities, utilities, and equipment are properly maintained and suitable for both GMP and developmental use. This will involve authoring, reviewing, and updating GMP procedures and documentation, with an emphasis on Qualification/Validation plans and annual reports for equipment, critical utilities, and computer systems.
Executing qualifications, commissioning, change controls, and decommissioning activities, as well as maintaining applicable GMP documentation such as engineering drawings and equipment database tracking, are part of the responsibilities. The Engineer will also contribute to Quality Notification (QN) reporting, investigations, and related corrective action/preventive action (CAPA) activities. Timely and accurate responses to questions and observations during routine internal audits and regulatory inspections will be expected.
Supporting equipment/system changes, performing periodic reviews, and participating in Quality Management System (QMS) activities are also included in the role. Additionally, the Engineer will provide capital project support for both smaller and larger multi-disciplinary projects, working with site engineering and maintenance groups, as well as external vendor support. This support covers ongoing operations as well as the installation of new capital and facility improvements.
Education Minimum Requirement:
- Bachelor's Degree in Engineering or Science plus a minimum of 2 years of related industry experience.
Required Experience and Skills:
- Familiarity with Quality, cGMP, Safety & Environmental Policies and Procedures.
- Familiarity performing Root Cause Analysis and investigation
- Troubleshooting ability (mechanical/electrical/automation) and capital project (support).
- Ability to flexibly adapt to flow to the work across both Quality and Facility aspects to support the business.
- Effective organizational skills.
- Effective communication
- Strong computer skills
Preferred Experience and Skills:
- Engineering, maintenance & calibration experience of pharmaceutical processing equipment and utility systems.
- eVal - Paperless electronic validation system
- Experience with a Computerized Maintenance Management System (CMMS) and Computerized Calibration Maintenance System (CCMS)
- Familiarity with Planning and Scheduling practices as well as business/financial practices.
- The candidate should be able to work independently and lead or facilitate tasks successfully.
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we "follow the science" that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
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.
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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.
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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".
Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.
Expected salary range:
$83,100.00 - $130,900.00Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.
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:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
Not ApplicableShift:
1st - DayValid Driving License:
NoHazardous Material(s):
n/aJob Posting End Date:05/11/2024
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:R293339
PDN-9bf59d7d-70da-4a5e-8923-5f50681e8767
