Validation Engineering Manager
Company: emd serono
Location: Saint Louis
Posted on: January 2, 2026
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Job Description:
Ready to explore, break barriers, and discover more? We know
you’ve got big plans – so do we! Our colleagues across the globe
love innovating with science and technology to enrich people’s
lives with our solutions in Healthcare, Life Science, and
Electronics. Together, we dream big and are passionate about caring
for our rich mix of people, customers, patients, and planet. Thats
why we are always looking for curious minds that see themselves
imagining the unimaginable with us. This role does not offer
sponsorship for work authorization. External applicants must be
eligible to work in the US. Your role: You will be responsible for
defining and executing the validation strategy for the St. Louis
CDMO operations at the Cherokee site in accordance with the
appropriate GMP requirements for an API Contract Manufacturing
Organization. You will lead the Validation team to ensure the
execution of validation activities. Validation activities include
qualification and re-qualification of facilities, equipment,
computer systems, utilities, equipment cleaning, cleanroom
qualification, and process validation. Provides subject matter
expertise on validation activities including but not limited to,
qualification and re-qualification of facilities, equipment,
computer systems, utilities, cleaning (facility and equipment), and
process validation. Active participation with site projects and
multi-disciplinary teams with Manufacturing, Project Management,
Process & Analytical Development, Quality Control, Quality
Assurance, Packaging, Materials Management, Engineering, and
Maintenance to ensure successful implementation and coordination of
validation activities. Direct interaction with customers to
understand specific validation requirements, ensuring customer
needs are met specifically as an API Contract Manufacturing
organization. Responsible for the successful validation and
qualification of sub-contractors assuring subcontractors meet the
pertinent product, regulatory and corporate quality requirements.
Provide leadership and supervise activities and work assignments
for validation activities at the site such as: • Maintain Site
Validation Master plan. • Generates the Validation schedule, drives
execution of workload and monitors performance to plan and tracks
status of validation activities and documentation. • Approves
validation protocols prior to execution of work, ensuring content
is accurate and in a timely manner to meet schedule requirements. •
Plan and adhere to qualification and requalification schedules.
Establish and maintain system lifecycle documentation (e.g.
Validation Plans/URS/FRS/IQ/OQ/PQ/FAT/SAT/TM) and associated final
reports. • Evaluates data from executed validation protocols and
ensures summary reports are generated and approved, Ensuring
quality, accuracy, and completeness of commissioning,
qualification, and validation documentation and deliverables. •
Generates or approves Quality Risk Assessment documents in relation
to executed validation activities. • Assesses and closes deviations
related to closure of validation activities and raises CAPA’s as
required. • Actively participates in relevant change control
activities and risk evaluation systems as they pertain to
validation. Location: Onsite St. Louis, MO - Cherokee Site CDMO Who
You Are Minimum Qualifications: • Bachelor’s degree in an
Engineering or Life Sciences discipline and/or equivalent years of
practical experience • Minimum five years’ experience of a similar
role within a cGMP environment is essential, complimented with
basic project management knowledge. • 5 years of leadership (team
lead, supervisor, manager) with a proven track record of motivating
and managing a team of graduate level staff. • Must be able to
apply a risk-based approach to operation and interpretation of
resulting data. Preferred Qualifications: • Experience in
interaction with regulatory bodies and development of audit
responses preferred. • Knowledge of API products and CMO is
desirable but not essential. • Ability to liaise with customer and
intercept their requirements. • Innovative, decisive,
results-oriented leader with strong coaching and problem-solving
skills. • Ability to multitask and prioritize independently in a
fast-paced environment. • Demonstrated ability to supervise and
develop staff and work effectively will all levels of organization.
• Excellent interpersonal, communication, and writing skills,
ability to analyze technical issues, define/solve problems,
establish project plans, statistically evaluate solutions, and draw
valid conclusions. Pay Range for this position:
$143,800-215,700
Keywords: emd serono, Saint Charles , Validation Engineering Manager, Engineering , Saint Louis, Missouri
