Jobs · Quality Assurance · Pennsylvania

Analytical Validation Engineer – Laboratory Operations - 175271

Piper Companies · Philadelphia, PA · 3 wk ago
On-siteQuality Assurance$60–$65/hrFull-time

About the role

Piper Companies is seeking an experienced Analytical Validation Engineer to support commissioning and decommissioning activities for a major pharmaceutical organization in Titusville, NJ. This role will support pharmaceutical laboratory operations, with a focus on laboratory instrument selection, installation, qualification, commissioning, and decommissioning within a regulated GMP environment. The ideal candidate will have hands-on experience with GMP laboratory instrumentation, laboratory equipment qualification, and investigations. This individual will also be comfortable managing multiple priorities independently while working closely with laboratory, quality, and cross-functional teams.

Responsibilities

  • Support laboratory commissioning and decommissioning activities within a pharmaceutical GMP environment.
  • Support laboratory instrument selection, installation, qualification, commissioning, and decommissioning.
  • Execute and support IQ/OQ/PQ activities for laboratory instruments and equipment.
  • Provide technical support throughout the laboratory equipment lifecycle.
  • Support laboratory investigations from initiation through completion.
  • Participate in root cause investigations and identify appropriate corrective and preventive actions.
  • Develop and implement CAPAs resulting from laboratory investigations.
  • Author and complete final investigation documentation.
  • Support multiple laboratory projects and activities simultaneously.
  • Collaborate with laboratory, quality, engineering, and other cross-functional stakeholders to resolve technical issues.
  • Apply analytical and critical-thinking skills to identify solutions to laboratory and equipment-related challenges.
  • Maintain compliance with applicable GMP requirements and established procedures.

Qualifications

  • Bachelor's degree in Chemistry, Biology, Biochemistry, or a related scientific discipline.
  • 5+ years of experience working in a GMP pharmaceutical environment.
  • Experience with pharmaceutical laboratory operations.
  • Hands-on experience with laboratory instrument selection, installation, qualification, commissioning, and decommissioning.
  • Experience supporting IQ/OQ/PQ activities.
  • Experience supporting laboratory investigations from beginning to end, including root cause identification, CAPA implementation, and final investigation report authoring.
  • Hands-on experience with GMP laboratory instruments, such as HPLC (particularly Waters), autotitrators, NIR, ICP, FT‑IR, particle counters, gas analyzers.
  • Ability to manage multiple projects and priorities simultaneously and independently.
  • Strong analytical, problem‑solving, and critical‑thinking skills.
  • Strong interpersonal and communication skills with the ability to collaborate effectively within a team environment.
  • Self‑starter with the ability to develop practical and innovative solutions to technical challenges.
  • Demonstrated flexibility and ability to work effectively with cross‑functional teams.

Compensation & Benefits

  • $60–$65/hour W2, based on experience
  • Medical, Dental, and Vision coverage
  • 401(k)
  • PTO
  • Sick leave as required by law
  • Paid holidays

Work Environment

This is an onsite position in Titusville, NJ, supporting pharmaceutical laboratory operations within a regulated GMP environment. The successful candidate should be comfortable working hands‑on with laboratory instrumentation while managing multiple projects and collaborating with cross‑functional teams.

Similar jobs