Process Development Technician

PSG Global Solutions; Andover (MA); On-site; USD 40,000 - 60,000; Full time

Job summary

PSG Global Solutions is seeking a motivated individual to join their team in Andover, Massachusetts. This role focuses on executing SOPs for unit operations, with a strong emphasis on purification processes and cGMP compliance.

The ideal candidate will be responsible for troubleshooting and supporting new technology implementations, maintaining daily operations, and ensuring a safe working environment. If you're ready to make an impact and grow in your career, apply today!

Qualifications

• 0-2 years of experience required.
• Thorough understanding of cGMP requirements and safety practices.
• Ability to perform skills training and provide subject matter expertise.

Responsibilities

• Execute SOPs for unit operations and maintain a safe working environment.
• Perform primary troubleshooting and act as a lead investigator for product/process deviations.
• Review documentation and monitor process compliance trends.

Skills

Purification

CIP/SIP experience

Previous cGMP experience

Education

High School Diploma

Job description

At Real we're always looking for new and ambitious people to help deliver exceptional service levels, change the lives of the candidates we represent and partner with some of the world's best pharmaceutical, biotechnology and medical companies.

As specialists in recognising talent we pride ourselves on not just finding the best people for our client partners but on our ability to spot the best and brightest talent to work for us. We are also renowned for providing training and long‑term career opportunities to help our employees be the best they can be, so they can continue to deliver the expertise Real has become famous for.

Relationships are at the heart of everything we do and ensure that our clients and candidates continue to work with us again and again. This ethos is also what shapes how we work as a business. We encourage and reward knowledge sharing and have various support networks and international forums to enable our employees to keep up‑to‑date with changes happening across their industries and share local insight to deliver true global perspectives.

Job Description

• Executes SOPs for unit operations (daily and long term).
• Includes CIP, SIP, and cleaning and sanitization of the facility.
• Operates of buffer/media make‑up tanks, glass washers, autoclaves, bioreactors, filtration equipment, inoculum preparation, chromatography skids, and UF/DF skids with varying mixes of automation and paper SOPs involved.
• Performs primary troubleshooting in time effective manner and act as a lead investigator SME of product/process deviations.
• Supports implementation of new technology for process execution and/or analysis. Interacts across the asset to achieve production schedule.
• Organizes daily routine when supervisors are not available.
• Reviews documentation daily as well as perform data entry – Monitor, identify and communicate process and compliance trends real time.
• Archives various documentation according to established procedures.
• Required to modify and/or create job‑related documentation including MBRs, SOPs, MFRs, work requests and others.
• Assist in inventory tracking, maintenance scheduling, and troubleshooting of mechanical equipment. Provides support during audits and with audit observation closure.
• Perform skills training and provide subject matter expertise to training materials.
• Maintains a safe working environment.
• Thorough understanding of cGMP requirements and safety practices.
• Employs Automated systems, enterprise systems, and available technology to execute work.
• Engages in and supports a culture of innovation and sustainable improvement through ownership of improvement for work processes, equipment and environment.
• Strives for Right first time execution through flawless execution and ownership of the process.
• Purification operational support in a large scale commercial manufacturing environment.
• 2nd shift rotating. The rotation would be 3 days on, 2 days off, 2 days on, 3 days off, 2 days on, 2 days off then it would repeat itself

Qualifications

Top 3 Critical Skills Required:

• Purification
• CIP/SIP experience
• Previous cGMP experience

EDUCATION:

• High School Diploma

EXPERIENCE:

• 0-2 years

Additional Information

All your information will be kept confidential according to EEO guidelines.