| Location | Paso Robles, CA |
Pharmaceutical GMP Quality, Validation & Contamination Control Consultants
Location: Central California (Paso Robles Area)
Work Arrangement: Primarily Onsite / Limited Remote Flexibility
Start: Immediate / ASAP
Schedule: Sustained onsite support anticipated; commitment based on project scope
Position Overview
We are seeking experienced Pharmaceutical GMP Quality, Validation, and Contamination Control Consultants to support an urgent quality and compliance improvement initiative at a pharmaceutical manufacturing operation in Central California.
The engagement involves a pharmaceutical drug product incorporating a delivery device, with multiple prioritized workstreams spanning materials management, Contamination Control Strategy (CCS), validation planning, cleaning validation, manufacturing risk assessments, batch records, environmental monitoring, and electronic Quality Management Systems (eQMS).
Consultants will assess existing manufacturing and quality processes, identify compliance gaps, complete or improve technical documentation, and provide hands-on support implementing sustainable corrective actions aligned with applicable pharmaceutical cGMP requirements and EU GMP Annex 1 expectations.
The organization is seeking consultants with strong pharmaceutical manufacturing, validation, quality systems, and contamination control expertise. Depending on individual qualifications, consultants may be assigned to one or multiple workstreams, with priorities established according to operational and compliance needs.
Key Responsibilities
Materials Management & Storage Controls
Conduct onsite assessments of materials management practices, storage conditions, and facility space constraints.
Review procedures and physically evaluate receiving, handling, preservation, inventory management, storage locations, packaging, quarantine, and shipping operations.
Assess controls for quarantined materials, segregation of sterilized products, and movement of materials to and from sterilization providers.
Identify deficiencies involving material segregation, traceability, storage capacity, and prevention of product mix-ups.
Recommend practical procedural and operational improvements to strengthen GMP compliance.
Contamination Control Strategy (CCS)
Review and update the existing draft CCS to align with EU GMP Annex 1 requirements applicable to terminally sterilized products.
Evaluate existing contamination controls associated with pharmaceutical manufacturing, including facility controls, gowning, cleanroom cleaning, equipment cleaning, and excipient manufacturing.
Assess containment strategies for potent pharmaceutical compounds, including hormone-related contamination and exposure risks.
Identify gaps in existing contamination prevention and containment practices and recommend improvements.
Align the updated CCS with manufacturing procedures, site-specific gowning requirements, and cleaning procedures.
Support implementation of revised contamination control practices.
Master Validation Plan & Qualification Strategy
Review and complete the site's Master Validation Plan (MVP), ensuring appropriate coverage of manufacturing operations and drug-device combination product requirements.
Identify manufacturing processes, production equipment, testing equipment, and facility systems requiring qualification or validation.
Evaluate validation requirements for cleanrooms, microbiological laboratory equipment, and computerized systems supporting manufacturing and quality activities.
Assess qualification and validation requirements involving critical suppliers, including sterilization services and manufactured components.
Identify gaps in existing validation planning and coordinate with site personnel to complete the MVP.
Establish practical validation priorities and supporting documentation requirements.
Cleaning Validation — Product & Excipient Manufacturing
Develop a cleaning validation plan for the excipient manufacturing process, including equipment used for multiple products.
Identify worst-case or most difficult-to-clean substances and process residues.
Develop appropriate sampling strategies and identify analytical testing requirements.
Coordinate analytical testing activities, including evaluation of specific and nonspecific testing methods.
Identify critical product-contact surfaces for coupon cleaning and recovery studies.
Prepare cleaning validation protocols, support execution, evaluate results, and complete validation reports.
Cleaning Validation — Cleanrooms & Equipment
Review and update existing cleaning validation procedures for manufacturing cleanrooms and equipment.
Assess cleaning effectiveness and contamination risks associated with cleanroom operations and production equipment.
Develop cleaning plans and validation approaches appropriate for single-product manufacturing environments.
Support execution of cleaning validation activities and documentation of results.
Recommend improvements to cleaning procedures and associated contamination controls.
Manufacturing Risk Assessments & PFMEAs
Review and provide technical input on existing Process Failure Mode and Effects Analyses (PFMEAs).
Assess risks associated with manufacturing processes, equipment, facility operations, and product contamination.
Evaluate containment and personnel exposure risks associated with potent pharmaceutical compounds.
Recommend improvements to risk assessments, mitigation measures, and supporting documentation.
Collaborate with site personnel to ensure risk assessments accurately reflect manufacturing operations and existing controls.
Master Batch Records & Manufacturing Documentation
Review and provide technical input on Master Batch Records covering manufacturing and assembly operations.
Evaluate documentation for mixing, molding, subassembly operations, device assembly, sterile barrier packaging, sterilization, and final packaging.
Assess manufacturing instructions, process controls, traceability, and documentation consistency.
Identify gaps and recommend improvements to support compliant and reproducible manufacturing operations.
Site Master File (SMF)
Review the draft Site Master File for completeness, accuracy, and alignment with applicable GMP expectations.
Identify documentation gaps and recommend appropriate revisions.
Coordinate with site personnel to ensure the SMF accurately reflects manufacturing activities, facility systems, and quality operations.
Environmental Monitoring & Building Management System Validation
Assess environmental monitoring controls for manufacturing and storage areas, including temperature, humidity, and differential pressure monitoring.
Evaluate the existing Building Management System (BMS) and identify qualification, validation, and data integrity gaps.
Develop site-specific User Requirements Specifications (URS) and Functional Requirements Specifications (FRS), leveraging existing corporate documentation where appropriate.
Develop and execute BMS validation protocols and prepare final validation reports.
Evaluate whether historical system data can support retrospective validation activities.
Recommend improvements to environmental monitoring controls and associated documentation.
eQMS & Change Control
Assess existing electronic change control practices, including management of change records, action items, accountability, and implementation documentation.
Review applicable corporate change control procedures and work instructions.
Identify gaps involving change tracking, documentation, assignment of responsibilities, and formal closure of change activities.
Recommend improvements to existing change control processes or develop site-specific supplemental procedures where appropriate.
Support implementation of sustainable change control practices within the existing eQMS.
Required Qualifications
Significant experience in pharmaceutical manufacturing, GMP quality systems, validation, contamination control, or related technical compliance functions.
Demonstrated hands-on expertise in one or more of the identified technical workstreams.
Strong working knowledge of applicable pharmaceutical cGMP requirements and regulatory expectations.
Experience assessing manufacturing, validation, or quality system compliance gaps and developing practical corrective actions.
Ability to develop, review, and execute technical protocols, procedures, risk assessments, or validation documentation relevant to the assigned scope.
Experience collaborating directly with Manufacturing, Quality, Validation, Engineering, and other cross-functional site personnel.
Ability to independently manage assigned deliverables and drive technical improvements through implementation.
Availability to provide substantial onsite support in Central California.
Preferred Qualifications
Experience with sterile pharmaceutical manufacturing, terminal sterilization, or drug-device combination products.
Knowledge of EU GMP Annex 1 and pharmaceutical Contamination Control Strategies.
Experience with potent-compound containment, cleaning validation, and contamination risk assessments.
Experience developing or completing Master Validation Plans and equipment or facility qualification activities.
Experience with materials management, sterile-product segregation, and GMP manufacturing documentation.
Experience with Building Management System validation, environmental monitoring systems, and computerized system qualification.
Experience reviewing PFMEAs, manufacturing risk assessments, and Master Batch Records.
Experience with eQMS change control processes and site-specific quality system improvements.
Proximity to the Paso Robles area or ability to accommodate sustained onsite assignments.
Work Arrangement
This engagement requires substantial onsite support in the Paso Robles area of Central California, particularly for materials management assessments, facility walkthroughs, manufacturing evaluations, cleaning validation execution, and equipment or system qualification activities.
Certain documentation reviews, quality system assessments, validation planning activities, and related deliverables may be completed remotely when appropriate.
Local or regional consultants are strongly preferred due to the urgency of the work and anticipated onsite requirements. Immediate availability is highly desirable.
Ideal Candidate
The ideal consultant is an experienced pharmaceutical GMP Quality, Validation, Manufacturing, or Contamination Control professional with strong technical expertise and hands-on execution capabilities.
Successful candidates will be comfortable evaluating complex manufacturing and quality system gaps, working directly with site personnel, developing practical and compliant solutions, and completing technical deliverables in an active pharmaceutical manufacturing environment.
Consultants with specialized expertise in one or more of the prioritized workstreams are encouraged to be considered. Former FDA experience is not required.