Associate Specialist, Manufacturing Engineer; Onsite

Job Description

Pharmaceutical Operations and Clinical Supply is seeking a highly motivated individual for a Compliance and Continuous Improvement position to support specialty dosage forms and oral solid dosage GMP development activities. This role is primarily responsible for compliance and continuous improvement activities within the clinical supply Formulation Laboratory and Experimentation (FLEx) Center, Non‑Sterile team (880 FLEx Center). The successful candidate will own and train manufacturing support processes (safety, compliance, changeovers, root cause analysis, continuous improvement program) and lead the team through continuous improvement projects while managing and completing GMP documentation.

The position is based in Rahway, NJ and is 100% on‑site day‑shift.

• Lead process improvement activities in the oral solid dosage facility.
• Coordinate quick changeover activities on designated equipment trains.
• Define and improve standard work, SOPs, BTD, and overall production flow.
• Support standard Non‑Sterile processing as time allows.
• Ensure adherence to Good Manufacturing Practices and draft and review process steps, SOPs, quality procedures, safety, and environmental standards.
• Perform documentation activities on room and equipment logs and batch sheets in compliance with Good Documentation Practices.
• Develop experience to become a compliance and continuous improvement expert and share knowledge by teaching others.
• Execute GMP batch documentation in accordance with local and global operating procedures.
• Provide support to engineering and formulation staff on Good Manufacturing Practices, facility processes, maintenance, and batch‑specific items.
• Identify and document deviations and atypical events.
• Lead investigations and document as required.
• Execute equipment swabbing in support of the cleaning verification program.
• Support investigations and the implementation of corrective/preventive actions.
• Support external and internal audits, tours and inspections.
• Author or assist with the development of SOPs.
• Complete training and ensure it is up to date.
• Interface with engineering, safety, quality and maintenance personnel for improvement of current processes.
• Lead improvement initiatives.

Required Qualifications:

• Bachelor’s degree in Chemical Engineering, Pharmaceutical Sciences, Chemistry or related field.
• Independent planning, scheduling, and time‑management skills.
• Pass medical screening requirements for production with PAPR.
• Ability to move 50 lb.
• Ability to troubleshoot and resolve issues utilizing digital skill sets.

Preferred:

• Experience in GMP pharmaceutical plant operations and GMP/GDP knowledge.
• Working knowledge of regulatory requirements within GMP manufacturing facilities and demonstrated focus on details and proper execution of batch manufacturing.
• Experience with oral solid dosage processes such as tablet compression, encapsulation, spray drying, film coating, dry‑powder inhalers, drug‑product device assembly lines, isolators, containment technology.
• Experience working with Lean / Six Sigma and continuous improvement projects.
• Experience with PI Visions, equipment HMI use, SAP, calibration/maintenance database systems, Microsoft Office (Word, Excel, Outlook).
• Experience working with safety team on industrial hygiene monitoring, investigations, improvements, focusing on a safety‑working culture.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.

US and Puerto Rico Residents Only:
Candidates must be residents of the United States or Puerto Rico.

San Francisco Residents Only:
Qualified applicants with arrest and conviction records will be considered in compliance with the San Francisco Fair Chance Ordinance.

Los Angeles Residents Only:
Qualified applicants with criminal histories will be considered in accordance with the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

Salary range: $70,500 – $110,900 (annual). Benefits include medical, dental, vision, retirement benefits (401(k)), paid holidays, vacation and paid sick days. Incentives include annual bonus and long‑term incentive if applicable.

Job Posting End Date: 01/19/2026.