Process Development Technician II

Job Title: Process Development Technician II
Location: Andover, MA
Type: Contract
Compensation: $28.11
Contractor Work Model: On-Site
Hours: 40.0

Overview
Leading pharmaceutical company looking for an experienced Process Development Technician II. Ideal candidates should have a High School Diploma and 3-5 years of relevant experience in a manufacturing operations, preferably in biotech or pharmaceutical environments.

Responsibilities

• Execute manufacturing operations on the production floor for buffer/media make-up tanks, glass washers, autoclaves, bioreactors, filtration equipment, inoculum preparation, chromatography skids, and/or UF/DF skids with varying levels of automation.
• Follow SOPs for unit operations including but not limited to, CIPs, SIPs, Sanitization, etc.
• Implement execution and issue resolution related to process equipment commissioning, qualification, and validation.
• Drive troubleshooting, technical support/analysis, and resolution of equipment, automation, and process issues on the manufacturing floor.
• Ensure right first-time execution, review daily documentation timely, and perform data entry; monitor, identify, and communicate process and compliance trends in real time.
• Support the assigned audit lead for walkthroughs/GMP100s and observation improvements.
• Manage controlled documentation including SOPs, Manufacturing Batch/Formulation Records, and Forms.
• Collaborate with Subject Matter Experts for manufacturing operations in support of QTS investigations and CAPA implementations.
• Remain current with manufacturing curriculum and support training programs.
• Implement Lean Manufacturing, Sustainability, Operational Excellence initiatives; facilitate continuous improvement across manufacturing areas.
• Collaborate with cross-functional manufacturing assets to support manufacturing campaigns.
• Escalate issues through management levels when operations, safety, equipment, product supply, or quality compliance are at risk.
• Generate work requests when issues arise with manufacturing equipment.
• Proficient in enterprise systems supporting manufacturing operations, including SAP, LIMS, AMPS, PDOCS, and QTS.
• Maintain inventory accuracy, reconciliation, and task prioritization to support production sustainability metrics.

Requirements

• 3-5 years of relevant experience in manufacturing operations, preferably in biotech or pharmaceutical environments.
• Knowledge of SOPs, GMP, and validation processes.
• Proficiency with enterprise systems such as SAP, LIMS, AMPS, PDOCS, and QTS.
• Strong troubleshooting and technical support skills.
• Ability to work independently and as part of interdisciplinary teams.
• Excellent documentation and communication skills.
• High school diploma or equivalent; relevant technical training or certifications preferred.

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

Salary : $28