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Quality Engineering CAPA Manager
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Process Engineering Manager - Bloomington, United States - Simtra BioPharma Solutions
Description
For over 65 years, pharmaceutical and biotech companies have partnered with Simtra BioPharma Solutions (Simtra) to bring their sterile injectable products to market.
Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.
As such, at Simtra, there is a strong emphasis on quality and continuous improvement. We hold ourselves to the highest quality and regulatory standards.
While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support, and secondary packaging.
It is very rewarding industry to work in. Our teams are driven to help clients scale, innovate, and bring-life changing medicines to patients worldwide.
We are seeking a Process Engineering Manager to lead our process engineering team.
The ideal candidate will have a strong background in process engineering management and team leadership, with a proven track record of implementing process optimizations and driving reliability and robust processes.
What you'll do:
Lead a team of process engineers to develop and implement reliability programs and strategies for filling and packaging lines and mentor team members through training and coaching to build a high-performing and engaged team
Establish and maintain key performance indicators to monitor equipment reliability, availability, and improvement effectiveness
Collaborate with cross-functional teams to identify and prioritize improvement opportunities and drive implementation of solutions
Develop and manage budgets to support continuous improvement initiatives
Implement and maintain preventive maintenance programs to minimize equipment downtime and maximize production efficiency
Champion process improvement opportunities to reduce costs, streamline workflows, and enhance overall operational efficiency
Ensure compliance with regulatory requirements and quality standards in all engineering activities. Track and monitor successful and timely implementation and effectiveness of corrective actions and change controls.
Provide technical expertise and support for troubleshooting and resolving complex equipment, including investigation and authoring of nonconformance reports by team members.
What you'll bring:
BS in Engineering or related field (including technology degree)
8+ years of experience in pharmaceutical manufacturing with a focus on reliability engineering, maintenance, or process engineering
Proven experience in leading and managing a team
In-depth knowledge of reliability engineering principles, methodologies, and best practices
Strong project management skills with experience in leading and executing reliability improvement projects
Excellent analytical and problem-solving skills, with the ability to apply data-driven approaches to drive continuous improvement
Strong communication and interpersonal skills, with the ability to collaborate with cross-functional teams and communicate complex technical concepts to non-technical stakeholders
#IND-USOPS
#LI-TL1
The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.
Simtra is an equal opportunity employer.
Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
EEO is the LawEEO is the law - Poster Supplement
Pay Transparency Policy
Reasonable Accommodations
Simtra is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here
and let us know the nature of your request along with your contact information.
Data Privacy
To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:
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