Engineering Specialist
3 days ago
At LanceSoft, we are seeking a highly skilled Engineering Specialist - Regulatory Compliance to join our team. As a key member of our organization, you will be responsible for ensuring compliance to regulatory requirements of facilities, utilities, equipment, and analytical instruments qualification processes and activities performed in our Client, Morris Plains, NJ facility.
Key Responsibilities:- Support internal and external audits by taking a lead role on validation/qualification discussions.
- Provide leadership and guidance to complex qualification activities and projects.
- Manage multifaceted qualification activities with limited oversight.
- Coordinate qualification activities in compliance with corporate policy, local procedures, and regulatory expectations.
- Collaborate with Process Unit (PU), Manufacturing, Science and Technology (MS&T), Operations (OPS), Quality Control (QC), and Quality Assurance (QA) departments on qualification projects and plans and identify the "critical to quality" parameters impacting qualification activities.
- Prepare Qualification Master Plans, Risk and Impact Assessments, Protocols, and Summary Reports and coordinate review and approvals of the documents.
- Author/review/update/assist in developing departmental standard operating procedures (SOPs) and qualification programs.
- Conduct field execution of Installation, Operational, and Performance Qualification protocols.
- Assist PU, MS&T, OPS, QC, and QA colleagues, as necessary.
- Ensure that all activities are in compliance with cGMP, Health Authority regulations, and Client Policies.
- Determine qualification requirements based on a worst-case matrix approach for the site.
- Provide qualification solutions that meet regulatory requirements within budget, where applicable.
- Support/assist 3rd party/vendor qualification activities, if applicable.
- Support qualification/validation projects as allocated.
- Provide guidance and support of less knowledgeable qualification/validation associates.
- BS degree in a Scientific discipline or other related field with significant prior experience (10+ years).
- Fluent in speaking/writing in English.
- 10+ years of Pharmaceutical industry qualification experience with a strong focus on Equipment and Analytical Instruments.
- Four options of Medical Insurance.
- Dental and Vision Insurance.
- 401k Contributions.
- Critical Illness Insurance.
- Voluntary Permanent Life Insurance.
- Accident Insurance.
- Other Employee Perks.
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