Validation Engineer
Validation Engineer
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$ 88000 - 104000
1 Vacancy
Job Description
COMPANY DESCRIPTION
SynerG BioPharma Group and Sequoia Biotech Consulting recently merged in September 2024 uniting two industry leaders to create a new force in life sciences consulting. By combining our expertise in product development regulatory strategy quality and compliance and commercial manufacturing we are positioned to deliver fully integrated solutions across the development continuum.
We are helping to enhance human health. This merger strengthens our ability to accelerate groundbreaking therapies and help clients navigate the complex life sciences landscape with greater agility and confidence. Together we form a leading life sciences consultancy dedicated to empowering organizations to overcome complex challenges and accelerate the speed to market scale and quality of lifesaving innovations.
We work across a diverse range of clients and projects supporting many organizations through the most critical phases of the drug discovery approval product development technology transfer and commercial manufacturing process. We also equip our partners with the tools knowledge and expertise to streamline operations enhance quality and ensure compliance.
SynerG BioPharma Group was recently honored with BioSpaces prestigious Best Places to Work 2025 award for the second consecutive year along with many other awardwinning programs to make a career here truly lifeenhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees with a particular emphasis on culture career growth and development opportunities financial rewards leadership and innovation.
At SynerG and Sequoia we recognize that our team members are our most valuable asset. Join us in shaping the future where your talents are valued and your contributions make a meaningful impact.
For more information visit www.Sequoiabiotech/ or www.Synergbiopharma
POSITION OVERVIEW:
Sequoia is seeking a Validation Engineer to assist with the development and 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.
KEY RESPONSIBILITIES:
(This list is not exhaustive and may be supplemented and changed as necessary.
- 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 review and closure of validation life cycle documents (RA VP IQ OQ PQ TM VR).
- Write review and revise a variety of Installation Operation and Performance qualification/verification related documents including any or all of the following: SOPs validation/verification master plans guidelines and plans automation engineering design commissioning qualification or other technical documents user requirement specifications (URS) functional requirement specifications (FRS) detailed design specifications factory acceptance test documents (FAT) verification protocols and/or commissioning test procedures.
- Write reports to summarize validation/verification/commissioning and/or revalidation/verification/commissioning activities.
- Write procedures investigations protocols reports change controls etc. to support the Maintenance and Engineering departments.
- Perform P&ID Walkdowns. Perform Thermal mapping of temperaturecontrolled 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. The requirements listed below are representative of the education experience skills knowledge and abilities required. 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:
- 47 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 nontechnical 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 such as books and files weighing up to 25 pounds. The employee is occasionally required to stand stoop or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job including moderate noise level an indoor temperate environment and light levels that are bright and conducive to minimal eye strain typical for an office environment.
TOTAL REWARDS PROGRAM:
We define total rewards as compensation benefits remote work/flexibility development recognition and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan robust benefit offerings and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program company paid holidays flexible working hours and fully remote work options for most positions and the ability to work almost anywhere. However if a physical work location is more for you we have office locations in Greater Boston; San Diego CA; Boulder CO; and India.
COMPENSATION:
The expected salary range for this position is $88000 to $104000. Actual pay will be determined based on experience qualifications geographic location and other jobrelated factors permitted by law.
Applicants must have current work authorization when accepting a position at SynerG. Currently SynerG is unable to sponsor or take over sponsorship of an employment Visa at this time.
LEGAL STATEMENT
SynerG BioPharma Group and Sequoia Biotech Consulting are proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions including the recruiting hiring placement training availability promotion compensation evaluation disciplinary actions and termination of employment (if necessary) are made without regard to the employees race color creed religion sex pregnancy or childbirth personal appearance family responsibilities sexual orientation or preference gender identity political affiliation place of residence national or ethnic origin ancestry age marital status military veteran status unfavorable discharge from military service physical or mental disability or on any other basis prohibited by applicable law. SynerG BioPharma is an EVerify employer.
Employment Type
Full Time
