Sr Engineer

Job Description

Job Description

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Sr Engineer

C&Q Strategy & Planning

• Develop and implement the overall Commissioning & Qualification strategy aligned with project and regulatory requirements.
• Define system boundaries and identify direct/indirect impact systems.
• Lead risk assessments (e.g., ISPE Baseline, ASTM E2500) to determine qualification scope.
• Develop C&Q plans, schedules, and resource forecasting.

Commissioning Activities

• Oversee and/or execute commissioning activities including FAT, SAT, and field commissioning.
• Ensure systems are installed and operate per design specifications.
• Coordinate with vendors and contractors during startup activities.
• Review and approve commissioning documentation and test results.

Qualification Execution (IQ/OQ/PQ)

• Author, review, and approve qualification protocols (IQ, OQ, PQ).
• Ensure traceability from User Requirements Specifications (URS) through testing.
• Execute or oversee protocol execution and ensure proper documentation of results.

Documentation & Compliance

• Ensure all C&Q documentation complies with GMP, FDA, EMA, and internal Amgen standards.
• Maintain document lifecycle within electronic systems.
• Support data integrity and ALCOA+ principles throughout qualification activities.
• Prepare and support validation summary reports.

Risk Management & Change Control

• Lead and document risk assessments related to system qualification.
• Evaluate and manage change controls impacting validated systems.
• Assess impact of deviations and implement corrective and preventive actions (CAPA).

Cross-functional Coordination

• Collaborate with Engineering, Validation, Quality Assurance (QA), Manufacturing, and Supply Chain teams.
• Interface with system owners and technical authorities.
• Provide technical guidance and mentorship to junior engineers and project team members.
• Support project meetings, status reporting, and stakeholder communication.

Characterization Process

• Develop the characterization protocols.
• Execute the characterization activities.
• Develop and review the characterization reports

FUNCTIONS
General:
1. Complete complex or novel assignments requiring development of new and/or improved engineering techniques and procedures.
2. Develop engineering policies and procedures that affect multiple organizational units.
3. Supervise, coordinate and review work of a small staff of engineers, associates and/or technicians on an ongoing basis as well as on a project basis.
4. Employ advanced engineering techniques and/or modifications of advanced techniques within area of engineering expertise.
5. Apply knowledge of engineering principles and practices outside of area of discipline expertise to broad variety of assignments in related fields.
6. Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area.
7. Application of mature engineering knowledge in planning and conducting projects.
*Other functions may be assigned

Design Engineering :
1. Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.
2. Work with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing requirements and recommendations for large and/or highly complex system/facility modifications.
3. Work with project managers to complete design and engineering projects within schedule, budget and quality constraints.
4. Coordinate the work of consultants, architects and engineering firms on development of standard design documents.
5. Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project

EDUCATION
-Masters + 2 years of Engineering experience OR
-Bachelors in Engineering + 4 years of Engineering experience.

COMPETENCIES/SKILLS
1. Working knowledge of pharmaceutical/biotech processes
2. Familiarity with validation processes
3. Familiarity with documentation in a highly regulated environment
4. Ability to operate specialized laboratory equipment and computers as appropriate.
5. Ability to interpret and apply GLPs and GMPs.
6. Ability to apply engineering science to production.
7. Able to develop solutions to routine technical problems of limited scope

Demonstrated skills in the following areas:
-Problem solving and applied engineering.
-Basic technical report writing
-Verbal communication
-Comprehensive understanding of validation protocol execution requirements.
-Basic technical presentationso Personal Organizationo Validation Protocol Writing
-Dealing with and managing changeo Technical (Equipment Specific)
-Analytical Problem Solvingo Computer Literacy
-Specialized equipment/process expertise
-In-depth knowledge of validation processes and requirements as applied to new equipment installations
-Interacts effectively with variety of communication and working styles
-Ability to independently determine when additional internal resources are required to solve problems
-Ability to handle multiple projects at one time
-Schedule development to Facilitation
-Collaboration
-Basic project managemento Completion and follow-up
-Established expertise in at least 3 separate areas of engineering technology.
-Ability to independently determine when additional external resources are required to solve problems
-Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope
-Problem solving skills requiring the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach
-Working knowledge of financial analysis tools
-Ability to delegate and manage the project work of others

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.