Senior Validation Engineer - Onsite Pharma Equipment

Actalent; Costa Mesa (CA); On-site; USD 117,000 - 130,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Paid time off

Job summary

Actalent is seeking a Senior Validation Engineer to support IQ/OQ/PQ execution on pharmaceutical manufacturing equipment in a sterile environment. This hands-on role on the manufacturing floor requires writing protocols, reviewing results, and delivering final validation reports while partnering with Manufacturing, Engineering and Quality.

Required: 7+ years in validation, GMP knowledge, experience with aseptic systems, autoclaves, lyophilizers, HVAC, WFI/ CIP/SIP, and strong technical writing

Qualifications

• 7+ years of validation experience within pharmaceutical or biopharmaceutical manufacturing.
• Experience working in sterile, aseptic, or injectable manufacturing environments.
• Strong hands-on experience executing IQ/OQ/PQ.
• Ability to independently write protocols, execute testing, analyze results, and complete reports.
• Experience qualifying pharmaceutical manufacturing equipment and/or critical utilities.
• Strong technical writing and documentation skills.
• Comfortable spending significant time on the manufacturing floor performing validation work.
• Working knowledge of GMP requirements and regulated pharmaceutical manufacturing.

Responsibilities

• Author and execute IQ, OQ, and PQ protocols for pharmaceutical manufacturing equipment and systems
• Perform hands-on field execution of qualification activities
• Review and analyze test results and prepare final validation reports
• Investigate and document discrepancies or deviations identified during protocol execution
• Support qualification of equipment such as: Aseptic filling systems, Autoclaves, Lyophilizers, Isolators / RABS, CIP/SIP systems, Sterile filtration systems
• Support qualification of critical utilities including WFI, clean steam, HVAC, compressed air, and nitrogen
• Participate in process validation, cleaning validation, and aseptic manufacturing activities
• Support change controls, deviations, CAPAs, and risk assessments
• Maintain validation activities in accordance with applicable FDA/cGMP and global regulatory requirements
• Partner with Engineering, Manufacturing, Quality, and Operations throughout validation projects

Skills

Validation

pharmaceutical manufacturing

Pq

Oq

Iq

Gmp

Engineering

Validation protocols

Process validation

Report writing

filling machine

aseptic

isolators

SIP

CIP

lyophilizers

autoclaves

hvac

plcs

plc troubleshooting

Automation

Education

Bachelor's degree in Engineering, Life Sciences, or related technical discipline

Tools

Aseptic filling systems

Autoclaves

Lyophilizers

Isolators / RABS

CIP/SIP systems

HVAC

WFI

PLCs

PLC troubleshooting

Job description

Actalent is seeking a Senior Validation Engineer to support IQ/OQ/PQ execution on pharmaceutical manufacturing equipment in a sterile environment. This hands-on role on the manufacturing floor requires writing protocols, reviewing results, and delivering final validation reports while partnering with Manufacturing, Engineering and Quality.

Required: 7+ years in validation, GMP knowledge, experience with aseptic systems, autoclaves, lyophilizers, HVAC, WFI/ CIP/SIP, and strong technical writing