Senior Process & Validation Engineer
Senior Process & Validation Engineer
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Salary Not Disclosed
1 Vacancy
Job Description
Senior Process & Validation Engineer
Location: Charleston South Carolina US
SHL Medical is a world-leading provider in the design development and manufacturing of advanced self-injection devices. With a global team of 6000 employees we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors pen injectors and other drug delivery systems that ensure effective treatment for patients. Headquartered in Switzerland since 2018 with key operations in Sweden Taiwan and the US we are united by a commitment to innovation impact and growth. Together we empower our people to develop solutions that make a meaningful difference in the lives of millions of patients while fostering a supportive inclusive and dynamic workplace for our colleagues.
Job Overview
This role is embedded in the Manufacturing Engineering group within our Global Operations Engineering team at our new state-of-the-art device manufacturing facility in North Charleston South Carolina. This role serves at the intersection between process engineering and validation with the candidate expected to understand and support onsite validation activities as well as serving as a process SME driving improvements and supporting investigations and troubleshooting.
Main Responsibilities
- Serve as a process SME leading and supporting process introduction development troubleshooting and improvement initiatives at the site
- Lead and support acceptance and CQV activities (commissioning qualification and validation) for production equipment and processes including developing/authoring compliant validation plans and protocols as well as supporting the associated change control processes
- Collaborate internally and across departments to drive improvements to SHLs production equipment and associated processes
- Work with the broader validation team including global colleagues to drive efficiency simplicity and robustness in validation process updates
- Provide input and make updates to validation-related SOPs work instructions and guidelines to improve the overall validation lifecycle
- Work with fellow engineers to drive and support root cause analysis NCMR investigation and CAPA planning
- Provide support for internal and external audits and investigations both through validation documentation ownership as well as technical SME input
- Remaining up-to-date and ensuring compliance with current industry trends as well as Quality Systems ISO13485 cGMP and other relevant regulatory protocols
- Performs other related duties as assigned.
Skills and Qualification
- Bachelors degree in Engineering or equivalent education/experience required
- A minimum of 4 years of relevant experience as a Validation Engineer and/or Process Engineer preferably in in the medical device industry
- Demonstrated knowledge of regulations and standards that apply to the medical device industry (cGMP ISO13485 CFR 820 etc.)
- Understanding of the application of quality systems to the medical device industry
- Statistical analysis knowledge including an understanding of how to execute and interpret Design of Experiments (DOE).
- Knowledge of common problem-solving and Root Cause Analysis (RCA) methodologies. Six Sigma certification is a plus
Preferred:
- Ability to perform multiple tasks and prioritize workload.
- Effective analytical technical and problem-solving skills.
- Excellent intercultural and interdisciplinary communication skills
- Ability to work independently with strong attention to detail and focus on efficiency effectiveness and cost
- Passionate & committed self-starter with can do attitude team player and taking responsibility to get the job done
We Offer
- Competitive compensation package
- Modern working environment with state-of-the-art facilities and technologies
- Challenging assignments in a fast growing and innovative industry
- Position in a dynamic international team of highly skilled professionals
- Various opportunities for personal and professional development within a global organization
Please note that SHL is a drug free employer. This offer of employment is contingent upon your successful completion of various preemployment screenings including but not limited to a drug test employment verification reference checks and a criminal background check.
For more information on SHL Medical please visit:
Required Experience:
Senior IC
Employment Type
Full Time
