Validation Engineer
Company: Syner-G BioPharma Group
Location: San Diego
Posted on: June 27, 2025
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Job Description:
COMPANY DESCRIPTION: Syner-G BioPharma Group is a science-led,
strategic partner for life science companies. We provide integrated
regulatory and biopharmaceutical development services spanning
early development to post-market, along with operational strategy
and support. With a global team of 400 employees across North
America and India, our goal is to help our partners navigate the
complexities of product development and accelerate their journey to
market. We are a leading life sciences consultancy committed to
advancing human health by helping organizations bring life-saving
innovations to market faster, at scale, and with the highest
quality. Our team partners with a diverse range of clients across
the life sciences industry, supporting critical phases of the drug
development lifecycle, from discovery and regulatory approval to
technology transfer and the support in capital projects. We provide
strategic guidance and hands-on expertise to streamline operations,
enhance quality systems, and ensure regulatory compliance,
empowering our clients to navigate complexity and deliver impactful
therapies to patients worldwide. Syner-G BioPharma Group was
recently honored with BioSpace's prestigious "Best Places to Work"
2025 award, for the second consecutive year, along with many other
award-winning programs to make a career here truly life-enhancing.
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
Syner-G, 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.Synergbiopharma.com 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 throughout the
organization 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: (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, execution, 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 execution 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
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. 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 : Bachelor’s 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 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
$88,000 to $104,000. Actual pay will be determined based on
experience, qualifications, geographic location, and other
job-related factors permitted by law. Applicants must have current
work authorization when accepting a position at Syner-G. Currently,
Syner-G is unable to sponsor or take over sponsorship of an
employment Visa at this time. LEGAL STATEMENT: Syner-G BioPharma
Group is 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 employee’s 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,
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. Syner-G BioPharma
is an E-Verify employer.
Keywords: Syner-G BioPharma Group, Murrieta , Validation Engineer, Engineering , San Diego, California
