Job Description
The Enabling Facilities (EF) group within the Chemical Engineering Research & Development (CERD) Department is seeking a highly motivated individual to work in a fast-paced job that provides a high degree of technical and project management responsibility. The Specialist -Engineering position will report to the Associate Director, Engineering and will be a member of the EF Team at the Rahway NJ facility. This position will be located in the Prep Lab facility which is responsible for interfacing with scientists who are manufacturing drug substance to support early clinical studies, scaling up new chemistries, and exploring new technologies.
Responsibilities of the Specialist - Engineer include the following:
The engineer role at the Specialist level is a member of the Prep Lab team and will be responsible for working directly with the Prep Lab staff to support scientific teams who are using the Prep Lab facility. This support involves training scientists new to the Prep Lab, reviewing procedures with the teams prior to processing, ensuring that the labs and equipment in the facility are ready for the GMP and non-GMP work that the scientists need to perform, working with the scientists to set up their equipment and ensuring that labs and equipment are clean and turned over after use. When the scientists encounter equipment and processing issues, the Specialist will be engaged in troubleshooting to find safe and compliant solutions to those issues in a timely manner.
The Prep Lab is building a new potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) drug substance lab and the Specialist will become a subject matter expert for this lab, and also for the related smaller scale potent development lab in the facility. As the new lab is currently under construction, the selected candidate will contribute to equipment and facility design, commissioning/qualification, as well as other critical activity workstreams to enable lab startup. They will also become a subject matter expert for a Grade C lab in the facility.
The selected candidate is expected to be a key part of the Prep Lab team and foster a culture of collaboration, learning and innovation. They will work closely with the development engineers & chemists, compliance representatives, safety partners and other team members to ensure the quality and safe delivery of clinical supplies, and ultimately to enable flexibility and speed in the execution of the Company's pipeline. This role may support facility operations, support compliance investigations/change management, author GMP documentation and manage/lead engineers in any of our enabling facilities.
Additional Supported Areas:
As required and in addition to support of the Prep Lab the Specialist may provide direct support to other areas such as:
Small Scale Organics Pilot Plant (SSO): The SSO is a Good Manufacturing Practice (GMP) manufacturing facility in the Process Research and Development (PR&D) organization. The pilot plant's mission is to serve as PR&D's internal node for small molecule drug substance clinical manufacture, and as preferred site for first pilot of commercial small molecule processes, enabling gain of critical internal experience with scale-up of manufacturing GMP steps, demonstration of new manufacturing technology/processes, training opportunities for improved manufacturing process development and seamless tech transfer to commercial sites.
MACS : The Modality Agnostic Chemistry Scaleup (MACS) Center is a new potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned in Rahway, New Jersey.
Education Minimum Requirement:

• Bachelor's degree in Chemical Engineering, Chemistry, Biology, Pharmaceutical Sciences or related scientific field with minimum of 3 years relevant experience, or a Master's degree with 1 year of relevant experience.

Required Experience and Skills:

• Experience working in a GMP clinical or manufacturing supply facility.
• Experience with small molecule drug substance and/or biologics process development.
• Experience in supporting compliance investigations and change management.
• Familiarity with US and EU GMP and Safety compliance regulations
• Ability to prepare Standard Operating Procedures (SOP) and cGMP documents.
• Effective interpersonal and communication skills, both verbal and written.
• Excellent organizational skills to multi-task.
• Desire and willingness to learn, contribute and lead.
• Track-record of independent problem-solving.
• Experience with coordinating maintenance activities around processing activities to support reliable facility operation.

Desired Experience and Skills:

• Experience operating/maintaining pilot scale or prep lab (kg) scale equipment.
• Experience providing technical mentorship.
• Experience with Potent Compound processing and containment systems (e.g., isolators).
• Experience with Quality systems

NOTICEFORINTERNALAPPLICANTS
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.
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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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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 - $130,900.00
Available 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 .
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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:
Domestic
VISA Sponsorship:
No
Travel Requirements:
No Travel Required
Flexible Work Arrangements:
Not Applicable
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
N/A
Job Posting End Date:
06/6/2024
*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:R294988