BioSpace, Inc.
Overview
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Validation Engineer
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BioSpace . Company: Syner-G BioPharma Group is a science-led, strategic partner for life science companies providing integrated regulatory and biopharmaceutical development services from early development to post-market, with a global team across North America and India. Position Overview
We are 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 by defining, implementing, and maintaining the validation program. Work Location:
Travel to client sites may be required up to 100%, based on project demands and client expectations. Key Responsibilities
Generate and execute life cycle documentation (FAT, SAT, IOQ, PQ) for cleaning, shipping, facilities, utilities, systems, equipment, and processes for (re)qualification/(re)verification. Support validation activities for Basecamp and client Tech Transfer projects, including generation, execution, review, and closure of validation life cycle documents (RA, VP, IQ, OQ, PQ, TM, VR). Write, review, and revise Installation, Operation, and Performance qualification/verification related documents, including SOPs, validation/verification master plans, guidelines and execution plans, automation, engineering design, commissioning, qualification, URS/FRS, design specs, FAT, verification protocols, and commissioning test procedures. Write reports to summarize validation/verification/commissioning and revalidation activities. Write procedures, investigations, protocols, reports, change controls, etc., to support Maintenance and Engineering departments. Perform P&ID walkdowns and thermal mapping of temperature-controlled chambers, warehouses, and SIP processes. Support the resolution of regulatory observations or manufacturing site issues. Execute periodic reviews and requalification for temperature chambers. Qualifications And Requirements
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties. Education
Bachelors degree in a related life science field. Technical Experience
4-7 years of experience within the biotech, pharmaceutical, or medical device industry. Knowledge and experience working with FDA cGMP, FMEA, and Risk Analysis required. Validation expertise in Equipment, CSV, Method, and Process. Protocol generation experience of automated production systems, with a concentration on computerized equipment and systems validation. Report writing experience for IQ, OQ, PQ, and CSV. Knowledge, Skills, And Abilities
Strong verbal and written communication skills and the ability to discuss technical topics with non-technical people is strongly desired. Essential Functions
Physical Demands : 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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 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 up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required include close vision and the ability to adjust focus. Work Environment
The work environment is typical of an office setting with moderate noise, indoor temperature, and lighting conducive to minimal eye strain. Compensation and Benefits
The expected salary range for this position is $88,000 to $104,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. Total rewards include base salary, benefits, remote work options, paid time off, holidays, flexible hours, and potential remote work for most positions. Legal Statement
Syner-G BioPharma Group is an Equal Employment Opportunity and Affirmative Action employer. All employment decisions are made without regard to race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, age, marital status, military veteran status, or disability. Syner-G BioPharma is an E-Verify employer. For more information, visit www.Synergbiopharma.com #J-18808-Ljbffr
Join to apply for the
Validation Engineer
role at
BioSpace . Company: Syner-G BioPharma Group is a science-led, strategic partner for life science companies providing integrated regulatory and biopharmaceutical development services from early development to post-market, with a global team across North America and India. Position Overview
We are 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 by defining, implementing, and maintaining the validation program. Work Location:
Travel to client sites may be required up to 100%, based on project demands and client expectations. Key Responsibilities
Generate and execute life cycle documentation (FAT, SAT, IOQ, PQ) for cleaning, shipping, facilities, utilities, systems, equipment, and processes for (re)qualification/(re)verification. Support validation activities for Basecamp and client Tech Transfer projects, including generation, execution, review, and closure of validation life cycle documents (RA, VP, IQ, OQ, PQ, TM, VR). Write, review, and revise Installation, Operation, and Performance qualification/verification related documents, including SOPs, validation/verification master plans, guidelines and execution plans, automation, engineering design, commissioning, qualification, URS/FRS, design specs, FAT, verification protocols, and commissioning test procedures. Write reports to summarize validation/verification/commissioning and revalidation activities. Write procedures, investigations, protocols, reports, change controls, etc., to support Maintenance and Engineering departments. Perform P&ID walkdowns and thermal mapping of temperature-controlled chambers, warehouses, and SIP processes. Support the resolution of regulatory observations or manufacturing site issues. Execute periodic reviews and requalification for temperature chambers. Qualifications And Requirements
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties. Education
Bachelors degree in a related life science field. Technical Experience
4-7 years of experience within the biotech, pharmaceutical, or medical device industry. Knowledge and experience working with FDA cGMP, FMEA, and Risk Analysis required. Validation expertise in Equipment, CSV, Method, and Process. Protocol generation experience of automated production systems, with a concentration on computerized equipment and systems validation. Report writing experience for IQ, OQ, PQ, and CSV. Knowledge, Skills, And Abilities
Strong verbal and written communication skills and the ability to discuss technical topics with non-technical people is strongly desired. Essential Functions
Physical Demands : 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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 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 up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required include close vision and the ability to adjust focus. Work Environment
The work environment is typical of an office setting with moderate noise, indoor temperature, and lighting conducive to minimal eye strain. Compensation and Benefits
The expected salary range for this position is $88,000 to $104,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. Total rewards include base salary, benefits, remote work options, paid time off, holidays, flexible hours, and potential remote work for most positions. Legal Statement
Syner-G BioPharma Group is an Equal Employment Opportunity and Affirmative Action employer. All employment decisions are made without regard to race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, age, marital status, military veteran status, or disability. Syner-G BioPharma is an E-Verify employer. For more information, visit www.Synergbiopharma.com #J-18808-Ljbffr