The Process Development Technician drives the technical execution of commercial and clinical production campaigns within a high-growth Biologics facility. This individual serves as a vital technical lead on the production floor, ensuring the seamless translation of complex processes into scalable patient therapies. By maintaining rigorous adherence to Standard Operating Procedures (SOPs) and fostering a culture of operational excellence, this role directly impacts the delivery of life-changing medicine.
location: Andover, Massachusetts
job type: Contract
salary: $25.00 - 28.71 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Leads the execution of complex unit operations, including bioreactor management, inoculum preparation, chromatography, and UF/DF filtration sequences.
- Oversees critical utility support processes such as Clean-in-Place (CIP), Steam-in-Place (SIP), and equipment sanitization within automated environments.
- Facilitates the commissioning, qualification, and validation (CQV) of advanced manufacturing equipment to ensure site readiness.
- Directs real-time troubleshooting and technical analysis to resolve automation or process deviations, minimizing impact on production timelines.
- Ensures "Right First Time" documentation practices, performing real-time data entry and technical review of manufacturing batch records within SAP and LIMS.
- Collaborates with Quality Assurance and Subject Matter Experts (SMEs) to support QTS investigations and the implementation of robust Corrective and Preventive Actions (CAPA).
- Advances Operational Excellence by identifying process trends and leading Lean Manufacturing initiatives to enhance yield and sustainability.
- Coordinates cross-functional communication during manufacturing campaigns to escalate risks regarding safety, quality compliance, or product supply.
qualifications:
Required:
- Degree in scientific field
- Experience in a cGMP manufacturing environment, specifically within Biologics or Pharmaceutical sectors
- Demonstrated proficiency in operating large-scale bioprocessing equipment (Bioreactors, Chromatography skids, Autoclaves)
- Advanced knowledge of enterprise management systems such as SAP, LIMS, AMPS, or QTS
- Expertise in automated control systems (e.g., DeltaV) and electronic batch records
- Green Belt certification or formal training in Lean Six Sigma methodologies
- Proven experience leading technical workstreams during site inspections or regulatory audits
skills: Corrective and Preventive Actions (CAPA), Cleaning Validation, Aseptic Processing, Biologics Manufacturing, Batch Record, Bioreactor Operation
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
