Validation Engineer
Job Location:
Greenville, NC - USA
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
COMPANY DESCRIPTION:
A career here is life-enhancing.
At Syner-G we enable our people to build careers that impact positively on their quality of life. Through our expertise insight consulting and management skills we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful varied and thought-provoking work with a strategic emphasis a solutions-driven approach and significant real-world outcomes from science to delivery/success. To learn more about who we are and what drives us watch our company video here.
Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow we support them in their learning and we reward them in so many different return they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner.
Syner-G was recently honored with BioSpaces prestigious Best Places to Work 2026 award for the third 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.
POSITION OVERVIEW:
We are seeking a Validation Engineer with 4-7 years of experience to support validation activities across equipment utilities facilities computerized systems manufacturing processes and MES/eBR platforms within GMP-regulated environments. This role is responsible for developing executing reviewing and maintaining validation lifecycle documentation while ensuring compliance with regulatory requirements data integrity standards and internal quality procedures.
The Validation Engineer will support MES and eBR implementation and qualification activities working closely with cross-functional teams including Manufacturing Validation Automation IT/OT and Quality. The successful candidate will contribute to validation strategy execution documentation review and system release activities while ensuring alignment with GMP and computerized systems validation requirements.
KEY RESPONSIBILITIES:
(This list is not exhaustive and may be supplemented or adjusted as needed.)
- Generate and execute validation lifecycle documentation including FAT SAT IQ OQ PQ and validation reports for equipment utilities facilities computerized systems and other GMP-regulated assets.
- Provide validation support and oversight for MES and eBR implementation qualification and lifecycle management activities.
- Review requirements risk assessments traceability matrices test protocols deviations and validation reports to ensure compliance with approved validation methodologies.
- Review eBR workflows to verify alignment with approved manufacturing processes master batch records and regulatory requirements.
- Support compliance with 21 CFR Part 11 GMP data integrity and computerized systems validation (CSV) requirements.
- Assist with deviation investigations CAPAs change controls system releases and go-live readiness activities.
- Author execute review and maintain validation documentation including validation plans protocols reports SOPs URS FRS and design specifications.
- Support technology transfer projects by executing and documenting validation activities in accordance with project timelines and quality requirements.
- Prepare validation summary reports and support qualification and requalification activities.
- Participate in commissioning and qualification activities including system walkdowns and verification exercises.
- Support thermal mapping and validation activities for temperature-controlled environments and systems as applicable.
- Assist in the resolution of audit observations regulatory findings and manufacturing issues related to validation and computerized systems.
- Collaborate with Manufacturing Quality Engineering Automation and IT/OT teams to support successful project execution and operational readiness.
- Maintain validation documentation in accordance with quality system requirements and document control procedures.
QUALIFICATIONS AND REQUIREMENTS:
Education
- Bachelors degree in Engineering Life Sciences Computer Systems or a related technical field.
Technical Experience
- 4-7 years of validation experience within the pharmaceutical biotechnology medical device or other regulated life sciences industry.
- Experience supporting equipment qualification computerized systems validation (CSV) process validation or automation system validation activities.
- Experience authoring and executing validation documentation including IQ OQ PQ protocols and validation reports.
- Familiarity with risk-based validation methodologies and regulatory expectations within GMP environments.
- Experience supporting validation activities for MES eBR or manufacturing automation systems is preferred.
- Experience with MES platforms such as PAS-X PharmaSuite Syncade Opcenter or similar manufacturing systems is preferred.
- Experience supporting audits inspections deviation investigations CAPAs and change controls is preferred.
Knowledge Skills and Abilities
- Understanding of GMP manufacturing operations 21 CFR Part 11 data integrity principles and computerized systems validation requirements.
- Demonstrated experience supporting MES/eBR validation or computerized system qualification activities in a regulated environment.
- Strong technical writing and documentation skills with attention to detail.
- Ability to review and interpret validation documentation process flows requirements specifications and test scripts.
- Strong organizational analytical and problem-solving abilities.
- Effective verbal and written communication skills with the ability to collaborate across multiple functional areas.
- Ability to manage multiple assignments and priorities in a fast-paced project environment.
- Working knowledge of validation lifecycle deliverables and quality system processes.
- Ability to work independently while contributing effectively within cross-functional teams.
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.
Currently Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time.
LEGAL STATEMENT:
Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employer. 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 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 is an E-Verify employer.
Required Experience:
IC
About Company
The world’s leading CMC & Regulatory Affairs solutions provider for biopharma. Consulting solutions in CMC 360, global regulatory affairs & medical writing.
