Process Engineering Manager
Arranta Bio is a rapidly growing and dynamic bio-pharmaceutical contract development and manufacturing organization (CDMO). Our vision is to be the best in class CDMO providing development and GMP manufacturing services to microbiome innovators within the pharmaceutical industry. Therapies focused on the human microbiome are exhibiting incredible potential towards revolutionizing disease etiology and associated medical treatments. Arranta Bio’s mission is to build a world class organization which provides microbiome bio-pharmaceutical innovators with a single source of supply from early process development through clinical and commercial GMP finished product.
WHO ARE WE
Arranta hires people who are committed and passionate to the goal of bringing life enhancing products to patients. We want top talent who will render ideas and a relentless desire towards accomplishing our mission; when a job becomes a passion, it makes you feel ALIVE.
Here at Arranta Bio, we embrace ALIVE - our core values that we live and breathe daily! We are Agile, Leading, Innovating, Value Creating, and Engaging.
We embrace our challenges as opportunities.
We are empowered to think and act.
We never settle; we strive to improve through purposeful creativity.
We build aligned teams who learn, grow, and deliver.
We are committed to building strong relationships.
Are you ready to come ALIVE with a daring and intrepid team? Don’t wait another minute; Apply today!
The Process Engineering Manager is responsible to supporting tech transfer, scale up, and GMP manufacturing of Plasmid processes. The position is responsible for leading, assessing and integrating new processes into the facility, including performing facility fit analysis, identification/procurement/start up of new process equipment, and authoring the transfer documentation. The Process Engineering Manager reports into the Head of Process Engineering.
ESSENTIAL JOB FUNCTIONS
- Responsible for tech transfer of client processes into Arranta’s facilities. Perform facility analysis, author tech transfer documentation and lead engineering batch execution.
- Lead equipment procurement and start up, including (but not limited to) authoring User Requirement Specifications, vendor and bid evaluations, drawings reviews, FAT/SAT/CQV support.
- Lead equipment start up, including Risk Assessments, Impact Assessments, Factory Acceptance Testing, Site Acceptance Testing, and CQV support.
- Author/review/approve SOPs and batch records.
- Design and implementation of custom single use technologies
- Partner closely with external (customer) and internal partners (Manufacturing, Quality, Process Development, Project Management) to facilitate successful engagements.
- Support ongoing GMP manufacturing including process optimization, deviation resolution, CAPA management, and change controls.
- Lead multi discipline teams to accomplish the above activities.
- Manage process engineering team including hiring input, career development, and reviews
- Other duties as assigned
Experience and Skills
- Chemical Engineering/Mechanical Engineering degree with 10+ years’ experience in biotech and/or pharma manufacturing
- Design and implementation of microbial fermentation technologies, including single use fermenters, single use TFF (UFDF and/or MFTFF), lysis, depth filtration, and chromatography.
- Design, development and procurement of single use technologies. Development of single use component flow diagrams (SUCFDs)
- Equipment procurement, including serving as end-user lead for project meetings, performing document/drawing reviews, and execution of FAT/SAT/CQV.
- Development of process flow diagrams (PFD).
- Author/review SOPs and batch records.
- A minimum of 5 years’ experience working in cGMP regulated environment, including working with change controls, deviations, and CAPAs.
- The employee is frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear.
- The employee is occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl.
- The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.
- Specific vision abilities required by this job include close vision, and ability to adjust focus.
- In the performance of the duties of this job the employee is required to travel occasionally, drive a motor vehicle.
- Communicate using telephone and e-mail.
- Phone reimbursement policy for qualified individuals
- Free parking
- Highly competitive healthcare with many plan options:
- Medical (HMO/PPO/EPO)
- Flexible Spending Accounts for medical expenses and dependent care expenses
- Up to 10 weeks of 100% paid maternity leave
- 2 weeks of 100% paid paternity, domestic partner, & adoption leave
- Educational assistance program
- 401k (traditional and Roth offered) with 100% match on first 5% deferred.
- A suite of Arranta Bio paid insurance coverage, including life insurance, short-term and long-term disability
- Voluntary legal assistance plan
- Employee Referral program
- Competitive PTO plan, in addition to 10 company paid holidays (includes 2 floating holidays)