Technician, Operations - Oral Solid Dosage / Inhalation

Job DescriptionPharmaceutical Operations and Clinical Supply is seeking highly motivated individuals for R&D Operations roles in our Rahway, NJ, Formulation, Laboratory, and Experimentation (FLEx) Center to support drug product development and GMP clinical supply of oral solid dosage, sterile, and specialty dosage forms. Positions will support development and clinical manufacturing and supply, as part of the FLEx-Sterile, FLEx-OSD, or RY119 team.This position will be responsible for hands-on processing activities that include room setup, equipment and material preparation, equipment assembly and disassembly, cleaning, and processing of raw materials into finished drug product. These individuals are expected to partner with and support formulation development colleagues in further understanding and knowledge capture of processes, which could include providing feedback on product and process development.These roles require adherence to GMP procedures, strong attention to detail in completing GMP documentation, proficiency in electronic systems, and participation in continuous improvement projects. Positions may also support commissioning, qualification, and demonstration of new equipment and technologies. Successful candidates will collaborate closely with team members and partner groups including formulators, engineers, Quality, Safety, and Facilities management to drive overall success and performance of the area and clinical pipeline.Key Responsibilities:

Prepares, operates, and cleans equipment and facilities used in clinical development and manufacturing processes.

Maintains, inventories, and transports required processing equipment, materials, supplies, and products.

Executes all documentation and clerical functions necessary to maintain good manufacturing practice (GMP) operations, using paper-based and electronic systems.

Maintains detailed knowledge of process equipment and operations. Troubleshoots equipment/systems to resolve issues and aid in technology and process development, capturing learnings to improve systems and processes.

Attends and actively participates in safety, quality, and process improvement initiatives to enhance flexibility, efficiency, and compliance.

Supports investigations and implementation of corrective/preventative actions.

Positions are 1st shift based in Rahway, NJ and 100% on-site.Education Minimum Requirements :

High School Diploma/GED or higher

Required Experience and Skills :

1+ years of relevant GMP Pharmaceutical experience, or equivalent (e.g. chemical, nuclear, military experience).

Demonstrated written and verbal communication skills.

Proficiency in computer systems and applications including but not limited to: Microsoft Office (Word, Excel and Outlook), Equipment HMI use, SAP, Calibration/Maintenance Database Systems.

Must be willing and able to lift 50 lbs, bend, stoop, squat, crawl, twist, climb ladders, and don & wear cleanroom protective gowning including respirators.

Demonstrated ability to work and communicate both independently and as a part of a team.

Preferred Experience and Skills :

At least 2 years GMP manufacturing/processing experience. Familiarity with regulatory requirements and Good Documentation Practices (GDP).

Experience with some of the following: highly complex and state of the art equipment, oral solid dosage, tablet compression, encapsulation, spray drying, film coating, dry powder inhalers, drug product device assembly lines, isolators, containment technology, aseptic filling using automated machinery, sterile manufacturing, visual inspection of product in glass vials, SAP or other ERP systems.

Associates Degree in science or related field.

BioWork Certificate (working in an FDA or similar regulated industry).

Experience with automated systems (MES, SAP, or similar).

Demonstrated troubleshooting / problem-solving skills.

NOTICE FOR INTERNAL APPLICANTSIn 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 separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.Under New York City, 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:$53,200 - $83,800Available 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 (https://www.benefitsatmerck.com/) .#EBRG#MSJR#vetjobsEmployees 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 (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)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 (https://survey.sogosurvey.com/r/aCdfqL) 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 (https://www.eeoc.gov/sites/default/files/2022-10/22-088EEOCKnowYourRights1020.pdf)EEOC GINA Supplement​Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp%20EnglishformattedESQA508c.pdf)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 (https://www.msdprivacy.com/us/en/CCPA-notice/)U.S. Hybrid Work ModelEffective 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 CarefullyMerck & 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:08/27/2024A 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: 08/27/2024A 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: R309120