process development technician - ii.

job summary:
The Senior Process Technician drives the execution of Commercial, Clinical, and/or Development production according to Standard Operating Procedures and Production Schedule. The Senior Process Technician will work on interdisciplinary self-directed teams, to define and implement process improvements, participate in process troubleshooting.

 
location: Andover, Massachusetts
job type: Contract
salary: $26.00 - 28.71 per hour
work hours: 9 to 5
education: High School
 
responsibilities:
- Executes 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.

- Executes the execution of SOPs for unit operations including but not limited to, CIPs, SIPs, Sanitization, etc.

- Implements the execution and issue resolution associated with process equipment commissioning, qualification and validation.

- Drives troubleshooting, technical support/analysis and resolution of equipment, automation, and process issues on the manufacturing floor.

- Drives for Right first time execution, the timely review of daily documentation and executes data entry; Monitor, Identify and/or Communicate process and compliance trends in real time.

- Supports the assigned audit lead for walkthroughs/GMP100s and observation improvements.

- View Role for controlled documentation; SOPs, Manufacturing Batch/Formulation Records, Forms, etc.

- Collaborates with the Subject Matter Expert for manufacturing operations in support of QTS investigations and CAPA implementations.

- Responsible for remaining current and reviews curriculum for training programs in support of manufacturing processes.

- Implements Lean Manufacturing, Sustainability, Operational Excellence initiatives; facilitate the drive towards continuous improvement in all manufacturing areas.

- Collaborateswith cross-functional manufacturing assets in support of manufacturing campaigns.

- Collaborates in the escalation process through various levels of management when operations, personnel safety, equipment functionality, product supply and/or quality compliance are at risk.

- Ensures work requests are generated when issues arise with manufacturing equipment.

- Proficient in enterprise systems to support manufacturing operations including but not limited to, SAP, LIMS, AMPS, PDOCS and/or QTS.

- Operates production sustainability through the performance of inventory accuracy, reconciliation and/or task prioritization to maintain metric adherence.

 
qualifications:
MINIMUM QUALIFICATIONS

- High School diploma or greater required.

- 3-5 years of relevant experience

PREFERRED QUALIFICATION

- Experience in a GMP manufacturing environment is desired.

- Familiarity and experience with either purification processes or mammalian cell culture.

- Ability to interpret and prioritize workflow to maintain the production schedule.

- Effective verbal and written communication skills.

 
skills: Laboratory Information Management Systems (LIMS), SOP Development, Good Manufacturing Practices (GMP), Corrective and Preventive Actions (CAPA)

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.