SUMMARY:
CPC Scientific is a globally recognized and leading CDMO specializing in synthetic peptide and oligonucleotide production, with one of the largest research peptide facilities in the world. CPC Scientific works directly with leaders in the biotechnology and pharmaceutical industries to bring life-changing therapeutics and diagnostics to market ranging from early drug discovery stages through clinical trials to commercial manufacturing.
CPC Scientific (CPC) is seeking to fill a full-time, on-site Validation Specialist position. This is a non-exempt, hourly role. Relocation will not be offered for this role. This position will report directly to QA Director and will work on executing, documenting and archiving full-spectrum validation activities for the new peptide CDMO facility in Rocklin, covering facilities, utilities, manufacturing equipment, lab instruments, computerized systems, cleaning, manufacturing processes and analytical methods. This role will develop and review validation protocols & reports in full compliance with FDA 21 CFR Part 210/211, ICH and cGMP; conduct on-site data collection, identify and resolve validation deviations. In addition, the role will collaborate cross-functionally on equipment commissioning, IQ/OQ/PQ and CSV computerized system validation. In addition, track validation status, perform change impact assessment and manage periodic re-qualification schedules. This role will support FDA and client audits, deliver validation training to production & lab staff. In addition, drive continuous improvement of validation workflows and implement risk-based validation approaches and finally ensure all facilities and processes remain regulatory-compliant and sustain permanent inspection readiness.
This position will interact with all levels within the organization. Professionalism and maintaining confidentiality are an integral part of the job.
DUTIES:
- Validation Planning & On-Site Execution
Execute full validation projects for peptide synthesis, purification, fill-finish facilities, utilities, manufacturing & lab equipment, computerized systems, cleaning, processes, analytical methods, temperature mapping and transportation qualification. Perform on-site commissioning, IQ/OQ/PQ after equipment delivery, collect complete raw data, identify deviations and participate in deviation investigations.
- Validation Document Lifecycle Management
Draft, revise and review validation protocols, reports and validation SOPs; track implementation of Validation Master Plan (VMP); manage full lifecycle of validation records, deliver compliant, traceable documentation ready for audit review.
- CSV & Change Control Governance
Conduct CSV validation for LIMS, CDS and other software systems; perform validation impact assessment for equipment, process and method changes, develop requalification plans within change control workflow.
- Deviation, CAPA & Audit Support
Participate root cause analysis for validation-related deviations, OOS and CAPA, formulate corrective actions; provide complete validation records during FDA, client and third-party audits, respond to audit inquiries and support remediation.
- Cross-Functional Collaboration & Project Support
Coordinate with engineering for new facility & equipment acceptance; partner with Manufacturing, QC and Process teams on technology transfer, process validation and cleaning validation; liaise with equipment vendors for validation technical support.
- Training & Continuous Improvement
Deliver GMP validation training to production and lab staff covering sampling, testing and data recording; monitor global regulatory updates, adopt risk-based validation methodologies to shorten cycle time and improve documentation efficiency.
- Team Support & Confidentiality
Assist supervisor with task allocation and provide guidance to junior validation staff; strictly protect confidential manufacturing processes, validation data and client information to safeguard site information security.
Competencies
- Technical Expertise: Sound knowledge of FDA, ICH and cGMP validation regulations, familiar with validation workflows for commercial peptide manufacturing;
- Planning & Execution: Able to manage multiple parallel validation projects, deliver on schedule with rigorous attention to detail and standardized data recording;
- Communication: Strong cross-functional coordination, clear written & verbal English communication skills;
- Stress Tolerance & Learning: Flexible overtime during site commissioning, quick to learn new equipment and regulatory requirements;
- Professionalism: High confidentiality awareness, rigorous compliance mindset and strong teamwork spirit.
Other Duties:
· Other duties as assigned.
Qualifications:
Education:
- Bachelor’s degree in Chemistry, Biochemistry, Pharmacy, Pharmaceutical Science, Analytical Science, Automation, Mechanical or other technical disciplines;
- GMP internal auditor or validation training certificates are a plus.
Work Experience
Minimum 3 years hands-on validation experience within GMP pharmaceutical / peptide / biotech CDMO environment, with full participation in equipment IQ/OQ/PQ, cleaning, process and analytical method validation; CSV validation experience highly preferred.
Essential Physical and Mental Requirements
Physical Requirements: e.g.,
§ Ability to sit at a desk for extended periods.
§ Ability to extensively use computer keyboard, mouse and monitor.
§ Ability to lift at least 25+/- pounds.
§ Ability to work in a venue such as an office location, hotel/conference room, etc., with the inclusion of working on the weekends.
§ Ability to walk, bend, stoop, kneel, twist, turn and use/walk up ladder/stairs, lift equipment parts, samples and paper archives, etc.
§ Ability to access manufacturing areas, clean rooms and equipment rooms with full required PPE.
Mental Requirements:
§ Ability to work with frequent interruptions and changes in workload priorities, ability to prioritize tasks, ability to maintain confidentiality.
§ Excellent analytical and organizational skills, able to manage multiple priorities and delegate responsibilities while maintaining quality.
§ Independent, and self-motivated individual able to work in a fast-paced team environment with tight schedules.
§ Ability to exhibit proficiency in English language skills during required work, e.g., reading, writing, and speaking and be responsive and able to work effectively as part of a team.
- Ability to use various systems such as MS Office, familiarity with LIMS, chromatography systems & validation tools preferred
Travel:
§ Ability to travel domestically by car or commercial means up to 10% of time.
§ Valid drivers’ license and insurance required.
The above is a list of essential duties and responsibilities for this position. This list is not all-inclusive. This job description may be modified at any time as needed.
CPC is an equal-opportunity employer. A pre-employment background check will be required.
Salary Range: $38.46 - $62.50 DOE
Pay: $38.00 - $62.50 per hour
Benefits:
- Dental insurance
- Employee assistance program
- Flexible spending account
- Health insurance
- Paid time off
- Tuition reimbursement
- Vision insurance
Work Location: In person
