Analytical Validation Engineer
Piper Companies · Philadelphia, PA · 1 wk ago
On-siteQuality Assurance$60–$65/hrFull-time
About the role
6‑month contract with potential for extension, onsite in Titusville, NJ. Piper Companies seeks an Analytical Validation Engineer to support commissioning and decommissioning activities for a major pharmaceutical organization in a regulated GMP laboratory environment.
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), auto‑titrators, 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.
Pay
$60–$65/hour W2, based on experience.
Benefits
- Medical, Dental, and Vision coverage
- 401(k)
- PTO
- Sick leave as required by law
- Paid holidays