Senior Engineer, Commercial Product Technical Knowledge
PerkinElmer is a global technology leader driving growth and initiative in the Environmental and Human Health Science markets. The company is a leading force in the development, production, marketing, servicing, and support of laboratory instrumentation and ancillary services throughout the world.Position Title: Senior Engineer, Commercial Product Technical Knowledge
Location: Lexington , MA
Type of Position: Full time
Role Purpose: Use applications of engineering, science and statistics to provide data analytics for biotechnology manufacturing operations.
- BS (or higher) n Biochemistry or Chemical Engineering or related disciplines with a minimum of 5 years of experience is required.
- Proven record of technical capabilities
- Have solid knowledge and/or experience with commercial biologics manufacturing including cell culture, purification and drug product
- Have experience in use of statistical software to support data trending, analysis and modeling
- Biotechnology development, manufacturing and/or manufacturing support experience
- Demonstrated experience in the use of software based statistical analysis tools.
- Demonstrated problem solving skills, particularly in terms of manufacturing process performance and trend evaluation.
- Strong working knowledge of cGMPs and regulatory guidelines for pharmaceutical products
- Demonstrated experience in supporting deviations, CAPAs and change controls.
- Experience leading or participating on cross-functional teams
- Proven ability to work in fast-paced environment with demonstrated capability to juggle multiple tasks and demands.
- Demonstrate teamwork/ collaboration and the ability to communicate appropriately and effectively.
- Be customer focused, results oriented and science driven
- Have the attitude to proactively participate in the identification, evaluation and potential implementation of new data evaluation and modeling technologies.
- Demonstrated ability to make risk based decisions.
- This person will have the ability to influence and drive technical rigor when leading/participating on cross-functional teams.
- Ability to make complex decisions regarding process control, capability, root cause analysis and process or product impact with input from manager.
- Candidate must be able to work in a dynamic environment and be able to set and balance priorities.
- Strong written and verbal communication skills
50% - Continuous monitoring and trending of in-process and release data for commercial drug substance and drug products in Rare Disease business unit including reporting, such as APQR, capability and control reports.
30% -Provide statistical analysis and modeling to support commercial manufacturing including evaluation of trends, deviations, change controls, CAPASs and continued process understanding and control.
15% - Generate metrics and dashboard reporting on drug substance and drug product in-process trends and release trends and process capability measurements.
5% - Prepare data analysis, summaries, and presentations to support regulatory observations
Benefits at PerkinElmer
Competitive base salary and incentive compensation plan / Job training and professional development / Comprehensive benefits package / Paid time off and holidays / Tuition reimbursement plan / 401(k) with match