Validations, Maintenance and Calibrations Specialist
About the role
withcontaining that summary. Then "Primary Responsibilities" list: many bullet-like sentences. We'll put under
Responsibilities
with- each.
We need to preserve all substantive info, not invent.
Responsibilities list includes:
- Schedule and perform validation studies to meet production and requalification, IQ, OQ, PQ, CV, and PV requirements.
- This position requires giving instruction to personnel in other departments over which he/she has no direct authority.
- Advise production managers and supervisors in the performance of validation activities and adapt the validation schedule to production requirements
- Coordinate validation activities with managers, supervisors, and technicians/operators from R&D, Manufacturing, Quality, Instrumentation, GMP, and Engineering
- Develop qualification and validation protocols/reports for manufacturing systems, processes, and equipment such as qualification/requalification, facilities, utilities, temperature-controlled areas, cleaning, etc.
- This position requires thorough knowledge of processes, equipment, and sterilization principles and concepts. This knowledge is used in the implementation of the "life cycle" approach to validation.
- Evaluate and analyze validation data collected during projects, verify adequacy of the information and compliance with regulations.
- validation-related activities of production, calibration, maintenance, quality, and others
- Perform pre and post calibrations of thermal monitoring equipment, place probes, and generate reports and graphs of data
- Perform routine requalification’s on schedule, including writing protocols, performing validation runs, analyzing data, writing reports, and assembling final validation packets
- Maintain accurate, succinct, and detailed documentation of activities and ensure paperwork from other departments is available and complete when required
- Ensure paperwork from other departments is available and complete when required (duplicate)
- Assist GMP, Quality, and various production personnel during inspections or audits conducted by internal groups or regulatory agencies
- Onboarding new equipment: coordinate/ lead creation of SOPs ensuring all operational, maintenance and calibration aspects are included
Also "Maintenance & Calibrations" section: we could incorporate into Responsibilities or separate? The posting has a subheading "Maintenance & Calibrations". We could treat as part of Responsibilities. But we could also create a separate section? The instruction: Prefer a few substantive sections over many thin ones. So we can keep under Responsibilities.
Then "Knowledge, Skills, And Abilities": list bullet points.
We can put under
Skills
maybe also include Knowledge? The heading list includes Skills. We'll put knowledge and abilities there. Then "Education And Experience Requires": we can put underRequirements
or Qualifications. The heading list includes Requirements, Qualifications. We'll put education and experience under Requirements. Then Pay: we have "The estimated pay scale for the Validations, Calibrations, & Maintenance Specialist role based in California, is $103,270.00 - $154,790.00 per year. Additionally, the position is eligible to participate in up to 8% of the company bonus pool." So we need a Pay section with that info. Benefits: "We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, life insurance, PTO, paid holidays and up to 5% 401(K) match and tuition reimbursement." Also "Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data." That's more about compensation; but we already have Pay. Could include that in Pay section? Might be okay. But we should not invent. We'll include Benefits section with the list. Schedule: Not mentioned explicitly; no schedule info. So we omit Schedule section. Also we have location: "Location: NORTH AMERICA : USA : CA-Vista:USVISTA - Vista CA-995 Park Center Drive-AC". Could be included maybe in About the role? But location is minor metadata; we could fold into a short p or drop. The instruction: do NOT put Job ID / requisition numbers as headings — fold minor metadata into a shortor drop it. So we could include location in a short p after About the role maybe. But we need to preserve all substantive information; location is substantive? It's minor metadata; we can include in a short p. We must remove boilerplate: EEO, legal, Third Party Agency notice, California Personnel Privacy Policy, etc. Also remove "Learn more about Grifols". Also remove "We are committed to offering our employees opportunities for professional growth and career progression." That's maybe fluff but still substantive? It's generic; but we could keep? It's not specific to role; but it's not boilerplate? It's a generic statement about growth; could be considered fluff. Safer to drop? The instruction: remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. This statement is not exactly boilerplate but could be considered generic fluff. Might keep? I'd keep it under About the role maybe? But it's not about role. Might be considered filler. I'd drop it. Also "Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us!" That's also generic company info; could be considered boilerplate? It's not legal but still fluff. Might drop to keep focus. We need to preserve ALL substantive information; but the instruction says prefer a few substantive sections over many thin ones. So we can drop generic fluff. Thus final HTML:
About the role
Fully on-site role embedded within the manufacturing team responsible for ensuring equipment and system readiness through validation, calibration, and preventive maintenance. The specialist must operate autonomously, lead validation efforts, and collaborate closely with R&D on new project implementation. This role will be dedicated to the Vista facility while providing validation support to all GBS locations and processes. Location: NORTH AMERICA : USA : CA-Vista:USVISTA - Vista CA-995 Park Center Drive-AC.
Responsibilities
- Schedule and perform validation studies to meet production and requalification, IQ, OQ, PQ, CV, and PV requirements.
- Give instruction to personnel in other departments over which the specialist has no direct authority.
- Advise production managers and supervisors in the performance of validation activities and adapt the validation schedule to production requirements.
- Coordinate validation activities with managers, supervisors, and technicians/operators from R&D, Manufacturing, Quality, Instrumentation, GMP, and Engineering.
- Develop qualification and validation protocols/reports for manufacturing systems, processes, and equipment such as qualification/requalification, facilities, utilities, temperature‑controlled areas, cleaning, etc.
- Apply thorough knowledge of processes, equipment, and sterilization principles and concepts in implementing the “life cycle” approach to validation.
- Evaluate and analyze validation data collected during projects, verify adequacy of information and compliance with regulations.
- Perform pre‑ and post‑calibrations of thermal monitoring equipment, place probes, and generate reports and graphs of data.
- Perform routine requalifications on schedule, including writing protocols, performing validation runs, analyzing data, writing reports, and assembling final validation packets.
- Maintain accurate, succinct, and detailed documentation of activities and ensure paperwork from other departments is available and complete when required.
- Assist GMP, Quality, and various production personnel during inspections or audits conducted by internal groups or regulatory agencies.
- Onboard new equipment: coordinate/lead creation of SOPs ensuring all operational, maintenance and calibration aspects are included.
- Maintain full oversight of all equipment in the facility requiring preventive maintenance and calibration.
- Ensure SOP oversight for existing equipment so that preventive maintenance and calibration requirements are clearly stated in existing operating procedures.
- Serve as the key liaison between manufacturing and third‑party providers to ensure proper maintenance and calibration is carried out.
Skills
- Strong knowledge of current Good Manufacturing Practices (cGMPs) operating procedures, validation standards and guidelines, and standard operating procedures.
- Certification in validation or maintenance management (e.g., ASQ, CMRT) as a plus.
- Strong critical thinking and problem‑solving skills; ability to identify errors and provide corrective action.
- Ability to work with others in a team environment.
- Proficiency with data acquisition systems and thermal mapping tools.
- Strong quantitative, analytical, organizational, and communication skills.
- Ability to lead projects and be proactive.
Requirements
- BS/BA degree in a related field such as STEM (Science, Technology (i.e. Industrial Technology), Engineering, and Mathematics). An equivalent combination of education and experience may be considered based on business need.
- Minimum 5 years of experience in validations within a GMP‑regulated manufacturing environment.
- Experience in maintenance and calibrations will be highly valued.
Pay
The estimated pay scale for the Validations, Calibrations, & Maintenance Specialist role based in California is $103,270.00 – $154,790.00 per year. The position is eligible to participate in up to 8% of the company bonus pool.
Benefits
- Medical, Dental, Vision, life insurance
- PTO and paid holidays
- Up to 5% 401(K) match
- Tuition reimbursement