Pfizer · 3 days ago

Process Engineer II - Technical Compliance

United States - Massachusetts - Andover

Full-time

Onsite

Senior Level

$65K/yr - $108K/yr

8+ years exp

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Responsibilities

Contribute to the completion of projects and manage own time to meet agreed targets.

Understand the fundamental business drivers for Pfizer and make decisions within organization's guidelines and policies.

Serve as technical support within your assigned group, collaborating with outside groups as needed.

Serve as the operations point of contact for campaign start-up CC, site assessment, impact assessment, generation of cGMP documentation, area preparation and summary reporting.

Audit Support during audits, ensuring smooth communication and providing necessary support and prepare comprehensive responses to audit findings, addressing each point with clarity and accuracy.

Oversee Corrective and Preventive Actions (CalOOTs), ensuring timely implementation and effectiveness.

Facilitate and initiate change control processes, including PTCs and EM-PTCs.

Collaborate with other departments to address corrective actions stemming from audits, inspections.

Conduct risk assessments and participate in revisions to ensure continuous improvement in compliance efforts.

Provide support for Quality Assurance Reviews (QAR) and Corrective and Preventive Action (CAPA) plans, ensuring compliance and effectiveness.

Lead and support in environmental and facility compliance activities, ensuring adherence to regulations and company standards. QAC Requests, CAS Reports to PQS Revisions

Analyze control deviations across multiple products and provide insights to the Site Quality Review Team (SQRT).

Facilitate and Conduct training sessions.

Monitor safety protocols and procedures on a day-to-day basis to maintain a safe working environment.

Prepare the manufacturing site for inspections by regulatory agencies through thorough walkthroughs and readiness assessments.

Conduct compliance walkthroughs for Manufacturing Operations (MamOps) suites to identify and address any non-compliance issues.

Revising technical documents related to compliance, ensuring accuracy and alignment with current regulations.

Support procurement and validation of new equipment and technologies for impact assessment.

Conduct skills training and provide subject matter expertise for training materials.

Qualification

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Computer literacyMicrosoft ApplicationsProcess tracking softwareVerbal communicationCoachingGuidanceTeamworkContinuous ImprovementProject ManagementGMP ManufacturingMammalian Cell CultureCentrifugationUltrafiltration