The Validation Manager will lead the Validation Department in the start-up, commissioning, qualification and validation of the New Albumin Purification and Aseptic Filling Plant. This will include the completion of conformance lots to meet FDA Submission filing timelines, as well as audit readiness and commercialization of the new facility.
Also under the Validation Managers Leadership will be the existing Packaging and Temperature Controlled Warehousing facility.
What your responsibilities will be
- Lead the effective planning, organization, development and resourcing of the Validation Department to ensure a successful start-up strategy is in place.
- Directs and oversees the qualification and validation of all relevant facilities, utilities, equipment, and processes to meet project timelines
- Ensures the review of specifications, drawings and documentation are critically assessed, participates in installations inspections, plans and coordinates performance testing, and writes, reviews and approves validation documents (protocols, reports, etc.) as required.
- Develop and lead Qualification timelines to ensure Project Team are aligned and committed to achieving overall project schedule
- Participate in regulatory and internal inspections/audits including providing written responses as applicable for areas of responsibility.
- Assists with activities and provides guidance to contract specialists when needed in support
- Participates during all phases of validation, FAT's, SAT's, etc and evaluates projects, provides guidance and technical information to others.
- Supports Installation Qualification activities in Engineering, checks operating parameters during Operational Qualifications, and coordinates with testing participants (Quality, Production) during Performance Qualifications, Performance Validation and Computer Validation activities
- Maintain current knowledge of regulatory and industry standards, trends and advancements through independent reading and training.
- Responsible for development of staff, including training and motivating in a manner that promotes the achievement of Company and department business goals and objectives.
- Leads the cross functional review of engineering drawings (Pipe & Instrument Designs, construction, as-built, flow diagrams) for compliance to Good Manufacturing Practices/ Validation principles.
Demonstrates technical knowledge and ability to changing circumstances.
Displays flexibility with assignments in different units
Demonstrates ability to influence others effectively
Makes decisions with designated assignments that influence the goals of the department
Produces anticipated results that contribute to business or technical goals.
Who you are
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
- Previous Pharmaceutical/ Bioscience/ Medical Device experience
- 6+ years Validation management experience
- BA/BSc in an Engineering or Scientific Discipline
- Demonstrated leadership skills with ability to motivate, guide, train, coach and develop subordinates.
- Strong organizational, analytical, problem-solving, skills. Ability to analyze detail and perform structured decision-making on a daily basis.
- Ability to manage multiple projects simultaneously, meet deadlines, and handle an ever changing, fast paced critical work environment.
- Ability to read and understand specification sheets, drawings, regulations (cGMP, QS, ISO).
- Knowledge of aseptic processing and filling, sterilization, GMP regulations and Quality operations an added advantage.
- Facility Start up experience an advantage
- Willing to travel domestically and internationally as required
What we offer
It's a brilliant opportunity for someone with the right talents.
Grifols understands you want a challenging and rewarding career in a critical function such as Corporate Communications. We'll help you grow professionally.
If you're interested in joining our company and you have what it takes, then don't hesitate to apply.
We look forward to receiving your application.
Grifols is an equal opportunity employer.
Contract of Employment: Permanent position