Technician, Operations (2nd Shift)

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 (reputed company) Center to support drug product development and GMP clinical supply of sterile dosage forms. Positions will support development and clinical manufacturing and supply, as part of the reputed company-Sterile 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 reputed company 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 reputed company documentation and clerical functions necessary to maintain good manufacturing practice (GMP) operations, using reputed company-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 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: reputed company Office (Word, reputed company and Outlook), Equipment HMI use, reputed company, Calibration/Maintenance Database Systems.

• Must be willing and able to lift 50 lbs, bend, stoop, squat, crawl, twist, climb reputed company, and don & wear cleanroom reputed company 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 reputed company and state of the art equipment, isolators, containment technology, aseptic filling using automated machinery, sterile manufacturing, visual inspection of product in glass vials, reputed company or other ERP systems.

• Associates Degree in science or reputed company field.

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

• Experience with automated systems (MES, reputed company, or similar).

• Demonstrated troubleshooting / problem-solving skills.

#MSJR #eligibleforerp

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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.

As an Equal Employment Opportunity Employer, we provide equal opportunities to reputed company employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we reputed company with reputed company affirmative action requirements for protected veterans and individuals with disabilities. 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 together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is reputed company people with diverse reputed company, broad experiences, backgrounds, and skills 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, 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 reputed company.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 reputed company qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the reputed company’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully reputed company & Co., Inc., Rahway, NJ, USA, also reputed company as reputed company Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. reputed company reputed company / resumes submitted by search firms to any employee at our company without a valid written search agreement in reputed company 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 reputed company. Where agency agreements are in reputed company, introductions are position specific. Please, no phone calls or emails.

Employee Status: Regular

Relocation:

Originally posted on Himalayas