Technician, Operations (2nd shift) - Oral Solid Dosage / Inhalation

Job Description

Pharmaceutical 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 Oral Solid Dosage 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.

This evening shift job will focus on spray drying production runs as well as cleaning and turnaround activities for oral solid dosage.

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.

• Operates Spray Drying system for production runs.

• Executes on assembly and disassembly of equipment for process turnaround.

• 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 2nd shift based in Rahway, NJ and 100% on-site. This position will start on days until training is complete, then shift to evening (2nd shift). Occasional day shift assignment weeks may be coordinated throughout the year for continual training purposes.

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 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 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 - $83,800

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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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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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, Monday - 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”.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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. 

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