Senior Validaiton Engineer

POSITION OVERVIEW:

We are seeking a CQV Engineer with 711 years of experience supporting commissioning qualification and validation activities for GMP-regulated facilities utilities equipment automation systems and manufacturing processes. This role is responsible for the execution of commissioning and qualification activities including system walkdowns protocol execution documentation review discrepancy management and system turnover support. The CQV Engineer will work cross-functionally with Engineering Construction Automation Operations Quality and project teams to ensure systems are installed tested documented and released in accordance with approved requirements project timelines and regulatory expectations.

KEY RESPONSIBILITIES:

(This list is not exhaustive and may be supplemented or adjusted as needed.)

• Review approved design vendor turnover and qualification documentation in preparation for commissioning and qualification execution activities.
• Support system walkdowns field verification activities construction completion reviews and readiness assessments.
• Execute commissioning and qualification protocols including IQ OQ PQ functional testing and other approved test documentation as applicable.
• Verify installation of equipment utilities instrumentation controls and automation systems against approved drawings specifications vendor documentation and design requirements.
• Verify system functionality alarms interlocks controls instrumentation and operational requirements during execution activities.
• Coordinate testing activities with Engineering Construction Automation Operations Quality Assurance and equipment vendors to support execution schedules.
• Perform and document field testing activities and collect objective evidence required to support protocol execution and qualification deliverables.
• Identify document and track discrepancies punch-list items protocol exceptions and deviations encountered during execution activities.
• Support investigations issue resolution corrective actions retesting and closure of execution-related deviations and discrepancies.
• Perform protocol data review and ensure documentation is complete accurate attributable and compliant with GMP documentation requirements.
• Review turnover packages and verify supporting documentation required for system acceptance and qualification.
• Develop and complete qualification summary reports turnover documentation and system closeout packages.
• Support system release and handover activities to Operations and Quality upon successful completion of required CQV deliverables.
• Maintain execution status and communicate progress constraints project risks and dependencies to CQV and project leadership teams.
• Participate in project meetings and collaborate with cross-functional stakeholders to ensure alignment with project schedules and milestones.
• Support regulatory inspections audits and quality initiatives as they relate to commissioning qualification and validation activities.

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 functions.

Education

• Bachelors degree in Engineering Life Sciences or a related technical discipline.

Technical Experience

• 711 years of commissioning qualification validation engineering or related experience within the pharmaceutical biotechnology medical device or other regulated life sciences industries.
• Strong understanding of FDA cGMP requirements GDP documentation practices and risk-based commissioning and qualification methodologies.
• Experience supporting commissioning and qualification activities for process equipment clean utilities facilities automation systems and manufacturing systems.
• Demonstrated experience executing and/or supporting IQ OQ PQ commissioning startup and functional testing protocols.
• Experience reviewing engineering documentation including P&IDs specifications equipment drawings turnover packages and vendor documentation.
• Familiarity with deviation management discrepancy resolution change control processes and quality systems.
• Experience supporting startup construction completion system turnover and operational readiness activities is preferred.
• Experience working in large capital project environments and collaborating with multidisciplinary project teams is preferred.

Knowledge Skills and Abilities

• Strong knowledge of commissioning qualification and validation principles within GMP-regulated environments.
• Ability to execute protocols in the field and effectively document testing results and objective evidence.
• Strong organizational skills with attention to detail and documentation accuracy.
• Excellent verbal and written communication skills with the ability to interact with stakeholders across multiple functional groups.
• Ability to manage multiple priorities and work effectively in a fast-paced project environment.
• Strong problem-solving skills and ability to support investigations issue resolution and risk mitigation activities.
• Ability to work independently while contributing effectively as part of a cross-functional project team.
• Proficient with Microsoft Office applications and electronic quality/documentation systems.

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 navigate production utility construction and manufacturing areas. The employee may occasionally be required to stand for extended periods climb stairs stoop kneel or lift and carry objects weighing up to 25 pounds. 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. Duties will be performed in a combination of office laboratory manufacturing utility and construction environments. The employee may be exposed to varying noise levels and active project areas while supporting field execution system walkdowns and qualification activities. Appropriate personal protective equipment (PPE) may be required when working in designated operational or construction environments.

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 $120000 to $140000 yearly. Actual pay will be determined based on experience qualifications geographic location and other job-related factors permitted by law.

Currently Syner-G is unable to sponsor or take over sponsorship of an employment visa at this time.