Syner-G
Validation Engineer
Boston, Massachusetts, United States
No sponsorshipDetected 19 days ago
VoIPGMPFDA RegulatoryMedical DevicesLeadershipCommunication
About the role
- Syner-G is seeking a Validation Engineer to assist with the development and execution of validation protocols for various types of processes.
- The Validation Engineer will be responsible for driving overall quality performance and compliance throughout the organization by defining, implementing, and maintaining the validation program.
Responsibilities
- Support validation activities for client projects, including generation, execution, review, and closure of validation life cycle documents
- Write procedures, investigations, protocols, reports, change controls, etc., to support the execution and closeout of validation work.
- Perform execution support activities including P&ID walkdowns, drawing reviews, and ETOP verification.
- Perform thermal mapping of temperature-controlled chambers, warehouses, and SIP processes.
- Support the resolution of regulatory observations or manufacturing site issues.
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.
Requirements
- To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
- Bachelor's degree in a related life science field.
- Knowledge and experience working with FDA cGMP, FMEA, and Risk Analysis required.
- Expertise in Process Equipment, Utilities, Clean Room, and/or Computer Systems validation.
- Knowledge, Skills, and Abilities:
- Strong verbal and written communication skills and the ability to discuss technical topics with stakeholders and non-technical people is strongly desired.
- The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job.
- While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse
- While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen.
- The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds.
Skills
- A career here is life-enhancing.
- Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact.
- For more information, visit www.Synergbiopharma.com
Compensation
- This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities.
Benefits
- This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities.
- Specific vision abilities required by this position include close vision and the ability to adjust focus.
- The requirements listed below are representative of the education, experience, skills, knowledge, and abilities required.
Company info
- We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars.
Equal opportunity
- LEGAL STATEMENT: Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employers.
Visa & Work Authorization
- Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time.
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This listing is sourced directly from Syner-G's careers page and normalized into a canonical job model.