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BioSpace · 2 days ago
Senior Engineer - Fractionation
Social Circle, GA
Full-time
Onsite
Senior Level
$84K/yr - $132K/yr
4+ years exp
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Responsibilities
Troubleshoot and provide resolution to technical issues to support ramp-up and steady-state operations of pharmaceutical manufacturing facilities.
Solve routine design and engineering tasks. Select sound techniques and make design recommendations under the direction of manager. Prepare technical reviews and responsible for organizing data and preparing appropriate documentation for assigned projects.
Evaluate and prepare product impact assessments for process exceptions.
Provide training and assistance to team members, manufacturing, and quality regarding analytical and process problems.
Make sound technical recommendations and contribute to technical feasibility analysis regarding projects/matters.
Independently plan and implement a series of design and technical tasks that may not be well-defined, have multiple variables, and require advanced techniques within negotiated deadlines.
Design new approaches to complex problems through adaptations and modifications of standard technical principles. Incorporate new methods and technologies for improving all products/processes.
Evaluate results relative to protocol requirements, definitions and study goals. Provide analytical interpretation of result from studies to partners.
Use statistical analysis to draw appropriate conclusions from the data.
Follow quality system, understand and apply applicable corporate, divisional and departmental procedures. Knowledge of related regulations and guidance (e.g., USP, ICH, and regional compendia) to facilitate compliance.
Present information to auditors.
Troubleshoot and provide resolution to technical issues to support ramp-up and steady-state operations of pharmaceutical manufacturing facilities.
Solve technical manufacturing issues, either lead teams or be an important member of the team.
Work with manufacturing to identify improvement opportunities.
Work with appropriate teams to implement improvement projects, including validation support and submission writing.
May work on small scale experiments.
Work with Manufacturing to help promote important metrics such as yields and capacity.
Support teams to resolve complex problems.
Author and implement process validation protocols and final reports (e.g. process performance qualification, mixing study, hold study). Coordinate and support training and execution of validation activities.
Promote the use of DMAIC tools in projects.
Analyze scientific, and statistical data to draw appropriate conclusions.
Practical and theoretical knowledge of the precipitation and purification of plasma proteins and biochemistry.
Experience with engineering principles in different scientific disciplines.
Discuss normally encountered technical and project management issues, both verbally and in written form.
Effectively communicate with teams and management and prioritize tasks and projects simultaneously.
Must be adept with engineering and project skills.
Must be experienced using MS Office software (Word, Excel and PowerPoint). Experience with Minitab or other statistical software preferred.
Participate in lead teams and work as a collaborative team member.
Individual that requires minimal guidance.
Experience with DOE (Design of Experiments), six sigma, and lean manufacturing a plus.
Qualification
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Required
BS engineering and 4+ years related experience
Knowledge of FDA-regulated manufacturing environments is desired
Practical and theoretical knowledge of the precipitation and purification of plasma proteins and biochemistry
Experience with engineering principles in different scientific disciplines
Experience with DOE (Design of Experiments), six sigma, and lean manufacturing a plus
Must be experienced using MS Office software (Word, Excel and PowerPoint). Experience with Minitab or other statistical software preferred
Preferred
Experience with engineering and project skills
Experience with statistical analysis and drawing conclusions from data
Experience with DMAIC tools in projects
Experience with small scale experiments
Experience with process validation protocols and final reports
Experience with troubleshooting technical issues in pharmaceutical manufacturing facilities
Experience with ramp-up and steady-state operations support
Experience with yield and process improvements
Experience with process compliance and validation activities
Experience with training team members on analytical and process problems
Experience with presenting information to auditors
Experience with promoting important metrics such as yields and capacity
Experience with resolving complex problems
Experience with discussing technical and project management issues
Effective communication with teams and management
Ability to prioritize tasks and projects simultaneously
Experience with working in a controlled environment with special gowning and protective clothing
Ability to work in a clean room environment for extended periods of time
Willingness to work shifts including nights, weekends, and holidays on an infrequent basis
Ability to travel on an infrequent basis
Certifications or professional licenses held
Benefits
Medical, dental, vision insurance
401(k) plan and company match
Short-term and long-term disability coverage
Basic life insurance
Tuition reimbursement program
Paid volunteer time off
Company holidays
Well-being benefits
Sick time up to 80 hours per calendar year
Paid vacation accrual up to 120 hours for new hires
Company
BioSpace
BioSpace is the leading online community for industry news and careers for life science professionals.
11-50 employees
Funding
Current Stage
Growth StageTotal Funding
$10M2000-08-24Series B· $10M
Leadership Team
J
Joshua Goodwin
CEO and President
K
Kristin Jones
Chief Revenue Officer
Recent News
2024-05-31
2024-05-05
2024-04-06
Company data provided by crunchbase
