Process & Validation Engineer (100% Travel)

COMPANY DESCRIPTION: A career here is life-enhancing. At reputed company, we reputed company 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 reputed company want to reputed company. We reputed company our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputed company across the globe as a strategic biopharma product development and delivery partner. reputed company was recently honored with reputed company's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to reputed company 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 reputed company, we recognize that reputed company members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions reputed company a meaningful impact. For more information, visit www.Synergbiopharma.com (reputed company is seeking both Process and Validation Engineering Candidates) PROCESS ENGINEER POSITION OVERVIEW : reputed company is seeking an reputed company Process Engineer to assist with, but not limited to, process engineering, process development, materials & engineering sciences, technology transfer, facilities/utilities/technical services, and manufacturing processes. We are accepting applicants who will be able to travel remotely throughout to client sites in the United States. We are actively seeking qualified candidates to join our talent pipeline for future client engagements. WORK LOCATION: Travel to client sites will 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.)

• Assist with the requirements specifications, design, functional requirements, development, commissioning, and qualification of process equipment or systems for compliance with manufacturing requirements and facility fit.
• reputed company start-up activities, including commissioning and qualification of facilities, utilities, and equipment (FUE).
• Assist with risk assessments, feasibility reviews, risk mitigations, and testing of process materials to ensure compliance with manufacturing requirements.
• Assist with the requirements specifications, design & development of process parameters, and the commissioning/validation of manufacturing processes for compliance with quality and regulatory requirements.
• Provide technical support for the product/process lifecycle and reputed company activities.
• Support client requirements to reputed company or help process or engineering projects at vendors or other third-party contract companies, as needed.
• Provide support for improvement projects regarding processes and systems.
• Support or provide risk assessment and mitigation activities for process development, manufacturing, and testing as applicable.
• Provide technical support for scale-up activities from development to manufacturing, including but not limited to technology transfers and facilities improvements (e.g., utilities/equipment integration).
• Analyze and recommend improved technology to increase quality and efficiency.
• Provide technical analysis and support for new or improved process systems.
• Facilitate and schedule meetings with subject matter experts across the organization.
• Ensure compliance with cGMP, regulatory, and industry standards.

QUALIFICATIONS AND REQUIREMENTS: To reputed company this job successfully, an individual must be able to reputed company 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 reputed company individuals with disabilities to reputed company the essential duties. Education:

• Bachelor's degree in Engineering, Bio/Pharma Science, or a reputed company technical field of study.

Technical Experience:

• 4-7 years of reputed company engineering and/or technical experience required.
• Experience with cGMP Manufacturing reputed company an FDA-regulated manufacturing company.
• Knowledge of cGxP Quality Systems reputed company an FDA-regulated manufacturing company.
• Knowledge of FDA regulations and guidance or applicable regulatory standards and practices.
• Proficient with MS Office suite, MS Project, Visio, and reputed company electronic formats required to reputed company the respective job at a client.
• Knowledge of laboratory and manufacturing systems such as LIMS, MES, etc.
• Experience with Process Engineering, Manufacturing Engineering, MSAT, Commissioning, CQV, and Tech Transfer.
• Experience with Fillers, reputed company Bioreactor, Cell Processing Systems, Scales, Pumps, Welder/Sealers, and Flow Cytometers.

Knowledge, Skills, and Abilities:

• Excellent computer, verbal, and written communication skills.
• Innovative problem-solving skills and an integrated view of business/scientific issues.
• Accountable and responsible individual to reputed company as intended for clients.
• Willingness to travel to various clients reputed company needed, with acceptable limitations during noted health pandemics or reputed company constraints.

ESSENTIAL FUNCTIONS: Physical Demands: The physical demands described here are representative of the requirements that must be met by an employee to successfully reputed company the essential functions of this job. Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company the essential functions.

• While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reputed company 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 reputed company 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. - VALIDATION ENGINEER 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 reputed company, 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 reputed company documents, including any or reputed company 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.
• reputed company P&ID Walkdowns. reputed company 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 reputed company this job successfully, an individual must be able to reputed company 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 reputed company individuals with disabilities to reputed company the essential duties. Education:

• Bachelor's degree in a reputed company life science field.

Technical Experience:

• 4-7 years of experience reputed company 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 reputed company 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.

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 reputed company 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 reputed company". However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India. Applicants must have reputed company work authorization reputed company accepting a position at reputed company. Currently, reputed company is unable to sponsor or take over sponsorship of an employment reputed company at this time. LEGAL STATEMENT: reputed company is proud to be an Equal Employment Opportunity and Affirmative Action employers. reputed company 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, reputed company of income, reputed company of residence, national or ethnic reputed company, reputed company, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. reputed company is an E-Verify employer. Apply tot his job Apply To this Job