The Pilot Plant Downstream Engineer plays a key role within R&D Pilot Operations serving as a critical technical link between labscale process development and fullscale GMP manufacturing. This engineer will independently execute both routine and complex downstream purification operations contribute to experimental planning support documentation development (SOPs batch records reports) and perform data analysis using Spotfire or equivalent tools. Leveraging broad knowledge of downstream processes industry practices and scientific principles the individual will consistently deliver highquality timely and reproducible results. Expertise in downstream operationssuch as harvest clarification chromatography filtration and buffer preparationis required. Experience with AKTA systems and Unicorn software is preferred. Familiarity with upstream pilotscale operations is also valued.
Accountabilities
80% Pilot-Scale Downstream Operations
- Execute nonGMP downstream purification activities at pilot scale (501000 L) to support new product development material supply process characterization and demonstration batches across the full development lifecycle including postlaunch programs.
- Partner with Process Development and Manufacturing Sciences to troubleshoot downstream issues and contribute to largescale process investigations.
- Manage operational details such as longlead material tracking sample planning equipment scheduling material ordering and vendor coordination.
- Independently collect interpret and trend process data; identify deviations patterns and opportunities for optimization.
- Present results technical challenges and proposed solutions in project and departmental meetings.
- Contribute to the drafting and revision of pilotscale procedures batch records and technical documentation supporting process transfers and scaleup.
- Support global technology transfer by providing technical insights process data and operational expertise.
- Assist with authorship of technical reports study protocols internal presentations andwhen applicablescientific abstracts or conference materials.
20% Technology & Digital Innovation
- Identify evaluate and integrate new pilotscale technologies and digital tools to enhance R&D operational flexibility and downstream process capability.
- Drive continuous improvement initiatives focused on efficiency process robustness and advanced data analytics.
Qualifications :
- Bachelors degree in Chemistry Biology Engineering Pharmacy or related field with 2 years of relevant industry experience or a Masters degree (industry experience preferred).
- Required: handson experience with downstream purification (chromatography UF/DF TFF depth/sterile filtration).
- Experience supporting nonGMP pilotplant operations at 501000 L bioreactor or equivalent downstream scale.
- Working knowledge of AKTA chromatography systems and Unicorn software preferred.
- Strong scientific problemsolving and data analysis skills.
- Excellent communication and documentation abilities.
- Effective collaborator able to work across multifunctional teams.
- Strong organizational skills with the ability to manage multiple priorities in a fastpaced environment.
- Proficiency with laboratory and pilotscale equipment; upstream familiarity is a plus.
- Ability to wear PPE and perform physical tasks including lifting up to 25 lbs standing up to 4 hours and climbing ladders or accessing equipment platforms.
- Authorized to work in the United States indefinitely without restriction or sponsorship.
Additional Information :
What to Expect in the Hiring Process:
- 10-15 Minute Phone Interview with Region Recruiter
- 45-60 Minute Virtual Interview with Manager and/or Group Leader
- 45-60 Minute Onsite to Meet the Team
The position is Full Time Monday-Friday 8am-5pm. Candidates currently living within a commutable distance of Lexington MA are encouraged to apply.
What We Offer:
- Excellent full-time benefits including comprehensive medical coverage dental and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
- Yearly goal-based bonus & eligibility for merit-based increases
- Hourly rate is between $30-34
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
Remote Work :
No
Employment Type :
Full-time
The Pilot Plant Downstream Engineer plays a key role within R&D Pilot Operations serving as a critical technical link between labscale process development and fullscale GMP manufacturing. This engineer will independently execute both routine and complex downstream purification operations contribute ...
The Pilot Plant Downstream Engineer plays a key role within R&D Pilot Operations serving as a critical technical link between labscale process development and fullscale GMP manufacturing. This engineer will independently execute both routine and complex downstream purification operations contribute to experimental planning support documentation development (SOPs batch records reports) and perform data analysis using Spotfire or equivalent tools. Leveraging broad knowledge of downstream processes industry practices and scientific principles the individual will consistently deliver highquality timely and reproducible results. Expertise in downstream operationssuch as harvest clarification chromatography filtration and buffer preparationis required. Experience with AKTA systems and Unicorn software is preferred. Familiarity with upstream pilotscale operations is also valued.
Accountabilities
80% Pilot-Scale Downstream Operations
- Execute nonGMP downstream purification activities at pilot scale (501000 L) to support new product development material supply process characterization and demonstration batches across the full development lifecycle including postlaunch programs.
- Partner with Process Development and Manufacturing Sciences to troubleshoot downstream issues and contribute to largescale process investigations.
- Manage operational details such as longlead material tracking sample planning equipment scheduling material ordering and vendor coordination.
- Independently collect interpret and trend process data; identify deviations patterns and opportunities for optimization.
- Present results technical challenges and proposed solutions in project and departmental meetings.
- Contribute to the drafting and revision of pilotscale procedures batch records and technical documentation supporting process transfers and scaleup.
- Support global technology transfer by providing technical insights process data and operational expertise.
- Assist with authorship of technical reports study protocols internal presentations andwhen applicablescientific abstracts or conference materials.
20% Technology & Digital Innovation
- Identify evaluate and integrate new pilotscale technologies and digital tools to enhance R&D operational flexibility and downstream process capability.
- Drive continuous improvement initiatives focused on efficiency process robustness and advanced data analytics.
Qualifications :
- Bachelors degree in Chemistry Biology Engineering Pharmacy or related field with 2 years of relevant industry experience or a Masters degree (industry experience preferred).
- Required: handson experience with downstream purification (chromatography UF/DF TFF depth/sterile filtration).
- Experience supporting nonGMP pilotplant operations at 501000 L bioreactor or equivalent downstream scale.
- Working knowledge of AKTA chromatography systems and Unicorn software preferred.
- Strong scientific problemsolving and data analysis skills.
- Excellent communication and documentation abilities.
- Effective collaborator able to work across multifunctional teams.
- Strong organizational skills with the ability to manage multiple priorities in a fastpaced environment.
- Proficiency with laboratory and pilotscale equipment; upstream familiarity is a plus.
- Ability to wear PPE and perform physical tasks including lifting up to 25 lbs standing up to 4 hours and climbing ladders or accessing equipment platforms.
- Authorized to work in the United States indefinitely without restriction or sponsorship.
Additional Information :
What to Expect in the Hiring Process:
- 10-15 Minute Phone Interview with Region Recruiter
- 45-60 Minute Virtual Interview with Manager and/or Group Leader
- 45-60 Minute Onsite to Meet the Team
The position is Full Time Monday-Friday 8am-5pm. Candidates currently living within a commutable distance of Lexington MA are encouraged to apply.
What We Offer:
- Excellent full-time benefits including comprehensive medical coverage dental and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
- Yearly goal-based bonus & eligibility for merit-based increases
- Hourly rate is between $30-34
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
Remote Work :
No
Employment Type :
Full-time
View more
View less